It can be difficult to figure out what products are worth your money in such a saturated beauty space, but here are two telltale signs: If celebrities recommend the product without being paid and if beauty editors, who get sent free products to test on the regular, say theyd spend their own money on it, chances are the product is worth a place in your routine.

Augustinus Baders The Cream (for combination and oily skin) and The Rich Cream (for dry skin) check both these boxes. The Creams word-of-mouth testimonials have given the product cult-level status. In fact, its been recommended three separate times in I Swear By This, a franchise where creatives share their must-have beauty products.

I felt like this product came out of nowhere; like one day, it popped up and everyone was recommending it. I have really sensitive skin, so Im typically hesitant to try new products, but I gave this a go. When I woke up the next day, I was a believer. Everything that everyone says about this cream is true. The price point is definitely on the higher end, but its so worth it. Grace Pae, celebrity makeup artist

"This has become central to not just my routine, but the routine of many of our customers. We were the first platform to launch this product, and it was really excitingthe whole experience of discovering this beauty holy grail. It's been a best-seller since it launched." Cassandra Grey, founder of beauty e-commerce platform Violet Grey

If its good enough for burn victims, its good enough for me. It's expensive, but some stuff you can't really put a price on. Plus, Im not using that much. My girlfriend buys it, so its all over the house. Basically, when she's not around, I use it, so I dont get slapped on the wrist.

This is an interesting product because its become the hot chick thing. They sell this at The Row; its the one. Every two to three years, theres a product like that. I don't even know if it's celebrity-driven because, with anything that becomes as big and popular as this, its just because it's good and it works.

Skin care and beauty are so personal. You can't just have beautiful packaging and marketing. It really does have to work, and there has to be a word-of-mouth element. That criteria doesn't exist in other categories. Chris Black, writer, consultant, and co-host of the podcast How Long Gone

Given all the hype the product has received, I decided to try it out myself. Below, my review on Augustinus Bader The Cream.

The Formula

In 2008, Augustinus Bader, a professor of applied stem cell biology and cell technology at the University of Leipzig in Germany, formulated a wound gel that heals third-degree burns, without surgery. The eponymous skin-care line was born from this breakthrough. The ethos behind Baders work is the idea that your skin doesnt need a never-ending supply of new ingredients.

Our skin contains stem cells, which have healing and regenerative properties. However, according to research, in order to trigger the self-renewal process, the environment needs to give the stem cells a green light to do their job. If theyre not receiving signals to activate, the skin stem cells lay dormant.

Both creams are formulated with Trigger Factor Complex, which contains vitamins, peptides, amino acids, and lipidsingredients that nourish the environment and signal to the dormant stem cells to wake up. Once the bodys stem cells are activated, the healing process promotes skin-care benefits like reducing redness, fading hyperpigmentation, and minimizing the appearance of fine lines and wrinkles.

The Results

After years of hearing the buzz about the brand, I decided to give it a try to see if the cream was actually as good as people say. I have combination skin thats prone to dehydration and dark spots, so I chose The Cream over The Rich Cream. The brand recommends using the product for at least 27 days (the amount of time it takes for cell turnover to occur). They also suggest using it alone, with no other skin-care products aside from cleanser. However, I decided to work The Cream into my existing morning and evening routines. After cleansing, Id apply the product before layering my other serums on top.

Before

After

The Cream played well with the other products in my routine. Its lightweight texture glided smoothly across my skin and the formula didnt dry down stickythere was no greasy residue left behind. My skin felt (and looked) plump after applying and it absorbed quickly. After a couple weeks of using The Cream, I started to notice a difference. My skin, which usually looks dull and extra parched in the mornings, felt supple and looked dewy. My stubborn dark spots were beginning to fade. Overall, my complexion looked healthier.

I still have a couple of weeks to go before I hit the 27-day mark, but The Cream has quickly become a staple in my routine. Yes, its pricey, but because of its clinically backed formula and proven performance, I think its absolutely worth the money.

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Augustinus Bader The Cream Review - Coveteur

Skin Stem Cells Comments Off on Augustinus Bader The Cream Review – Coveteur | April 15th, 2022

ASCE+ HRLVis the second product of ExoCoBio's professional aesthetic brand "ASCE+" whose first product "ASCE+ SRLV" for skin care is now widely recognized in a global market. ASCE+ HRLV is targeted for scalp rejuvenation and hair loss market and expected to rapidly expand its market share by introducing four effects: (1) scalp rejuvenation, (2) hair loss care, (3) improvement of hair anti-aging and (4) trouble prevention. They are designed to take care of both of scalp and hair regardless of age and gender.

According to the research conducted by Grand View Research (global market and research company), "the global hair and scalp care market size is valued at US$ 80.81 billion in 2020 and is anticipated to grow at a CAGR of 6.6% from 2021 to 2028." In recent years, there are growing concerns about the harmful effects of pollution, excessive use of hair products with chemicals, and the demand for nature-friendly products, whose market needs led to the launch of ASCE+ HRLV.

Dr. Iigo de Felipe, a Dermatologist with clinics in Barcelona and London, completed forthe last 2 years a clinical study for patients with scalp rejuvenation & hair loss using ASCE+ HRLV. When asked about his experience with the product, he said it is "better than other traditional treatments such as oral dutasteride, minoxidil or PRP" and praised its effectiveness affirming that it is "especially good in the frontal area of the scalp, an area where many other treatments usually fail". Dr. De Felipe also emphasized that "even though treatment is very effective for men, it is equally and sometimes even more effective for women too."

Over the past five years, ExoCoBio has made utmost efforts for R&D relating to skin, by using its patented technology "ExoSCRT" that is designed to isolate quality exosomes with excellent efficacy and to mass-produce exosomes (For more information on ExoSCRT, visit the following link: https://www.youtube.com/watch?v=ZOGQI8VuNOU). As a result, ExoCoBio became a global leader in exosome industry by obtaining 38 patents that are considered to be the strongest patent portfolio for exosomes in the world. Recently ExoCoBio successfully registered the patent "Composition for rejuvenating hair &, preventing hair aging comprising an exosome derived from stem cells as an active ingredient (Patent No. KR 10-2265875-0000)," which is the world first and unique idea to rejuvenate the hair color (i.e., hair returns to its original color).

"It is anticipated that the launch of ASCE+ HRLV will lead to expansion of ExoCoBio's share in the scalp rejuvenation and hair loss market as well as skin care market. In addition to the aesthetic product, ExoCoBio plans to develop a bio-medicine for hair loss through its R&D based on its innovative technology," stated Byong Cho, CEO of ExoCoBio (For HRLV technology, visit the following: https://www.youtube.com/watch?v=vkRcNCvNKAI).

References:https://www.grandviewresearch.com/industry-analysis/hair-care-markethttps://www.imcas.com/en/academy/show/11792/exosomes-in-treatment-of-androgenetic-alopecia-aga?connected=1

About ExoCoBio Inc. (www.exocobio.com)

ExoCoBio Inc. is the global leader who specializes in next generation exosome-based regenerative aesthetics, regenerative medicine, & immunotherapy. Currently ExoCoBio offers a series of exosome-based aesthetic & cosmetic products which are innovative and brand-new items in the regenerative aesthetics industry. Among them, ASCE+, EXOMAGE, and CELLTWEET are leading brands for skin rejuvenation, skin immune-modulation, and scalp rejuvenation, which have shown dramatic sales increase worldwide.

SOURCE ExoCoBio Inc.

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ExoCoBio launches "ASCE+ HRLV" for Scalp Rejuvenation and Hair Loss - PR Newswire

Skin Stem Cells Comments Off on ExoCoBio launches "ASCE+ HRLV" for Scalp Rejuvenation and Hair Loss – PR Newswire | April 15th, 2022

When a freak accident left mum-of-three Sam Bloom paralysed from the waist down, she sunk into a deep depression before finding comfort from an unlikely source.

Bloom stumbled across a baby magpie she called Penguin Bloom, and the bird soon became a member of her family - eventually helping to assist in her recovery.

Her book of the same name later became a movie, starring Australian actress Naomi Watts as Sam.

Watch The Morning Show on Channel 7 and stream it for free on 7plus >>

See Sam Bloom in the video player above

But that is far from the end of Blooms remarkable story.

She is both a world para-surf champion and disability advocate, fighting for a cure for spinal cord injuries.

When she joined The Morning Show, she started by discussing the impact of the film.

I think the best thing about the whole film and telling our story is just all the messages Ive received from people around the world, Bloom said.

It was on Netflix in South America and Europe and so on, and a lot of people have just said thank you because they dont feel so alone because it was a pretty honest account of when life doesnt turn out the way you thought it would.

Its nice to know that youre actually helping someone.

Bloom was an avid surfer before her accident, and her injury hasnt deterred her. She has twice taken out the world para-surf championship and recently returned from a surfing trip with her family in Yeppoon in north Queensland.

It was so much fun, the wave pool at Yeppoon is like a giant lake and its like it has this giant plunger in the middle and it sucks up, Bloom said.

Its a bit terrifying at first and then there are five different breaks - it is the best fun ever.

I feel super-free, kind of feel like my old self again, which is a nice feeling. Its the best.

Bloom also spoke about her work with Wings for Life World Run - the worlds largest running event in which thousands of people around the globe run simultaneously to raise money and awareness for spinal cord injury research.

The run is on May 8 at 9am in Sydney and the run starts all around the world at the same time, in a way were lucky that its not in the middle of the night in Sydney when it starts, Bloom said with a laugh.

Bloom explained the goal behind the run and her hopes for what it might ultimately achieve: funding vital research into spinal injuries.

Unfortunately its all about money, she said.

Thats the best thing about Wings for Life World Run, 100 per cent of the money raised goes straight to the research.

Its incredible, theyre doing a lot of research now with stem cells and neurostimulation.

I hope that theyll find a cure for spinal cord injuries. Can you imagine, theres millions of people around the world living with spinal cord injury and it breaks my heart when I see young people (affected).

Because I was 41 when I had my accident and I know how devastating it is, when you see young people and their journey is only just beginning.

Bloom revealed that, while her outlook is a lot more positive, she still struggles with living with her injury

I have good days and bad days, for sure, she said. To be honest, I hate being stuck in a wheelchair, Id do anything to be up and to be me again.

To help support the Wings for Life World Run please click here

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Still Blooming: Sams mission to raise money for spinal cord injury research - 7NEWS

Spinal Cord Stem Cells Comments Off on Still Blooming: Sams mission to raise money for spinal cord injury research – 7NEWS | April 15th, 2022

Scientists have created a stem cell treatment that might potentially lead to novel restorative therapies for those who have suffered a spinal cord damage.

Clinical trials have been hindered by limited stem cell viability and inability to replace injured spinal cord cells following spinal cord damage, despite its enormous promise for tissue healing.

Using a tailored method, this study establishes ground-breaking new territory by directing grafted neuronal stem cells to produce the specific kinds of spinal cord repair cells. It is critical that these newly generated cells survive and operate inside the host wounded spinal cord for a lengthy period of time following a spinal cord accident.

As a neurodegenerative ailment, spinal cord damage is a severe and expensive one, Karimi noted. She estimates that roughly 1,400 new occurrences of spinal cord injury occur annually in Canada, out of a total population of 86,000 people. Of them, 40% are all below the age of 45. It is anticipated that in 2019, the yearly cost of spine nerve lesion in Canada would be around $2.7 billion. She said that these expenses include medical treatment and hospitalizations, and also indirect expenses such as missed or decreased output.

Developing innovative restorative medicine therapies to enhance the standard of life for a wide group of people is an unfulfilled need in the field of spinal cord injury rehabilitation. This is exciting news for spinal cord injury sufferers, who have seen few advancements in treatment since the advent of stem cell research.

It will likely still be some time before this kind of treatment is available to patients, but we know that the researchers involved in this study are doing everything they can to advance neural stem cell transplantation therapies and bring them to a wider clinical application.

The study was published in The Journal of Neuroscience.

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Neural Stem Cell Therapy For Spinal Cord Injury To Tap Into The Potential Of Stem Cells - Optic Flux

Spinal Cord Stem Cells Comments Off on Neural Stem Cell Therapy For Spinal Cord Injury To Tap Into The Potential Of Stem Cells – Optic Flux | April 15th, 2022

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Lineage and Cancer Research UK Announce Completion of Patient Enrollment in Phase 1 Clinical Study of VAC2 for the Treatment of Non-small Cell Lung...

Spinal Cord Stem Cells Comments Off on Lineage and Cancer Research UK Announce Completion of Patient Enrollment in Phase 1 Clinical Study of VAC2 for the Treatment of Non-small Cell Lung… | April 15th, 2022

SUNNYVALE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for BCDA-04, a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive (NK1R+). This allows BioCardia to initiate its First-in-Human Phase I/II trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, with trial initiation expected in the third quarter of 2022.

The first part of the clinical trial will evaluate increasing doses of the NK1R+ MSCs and the optimal dose will be taken to Phase II in a randomized study in adult patients recovering from ARDS due to COVID-19. "This investigational cell therapy is administered intravenously (IV) and follows a significant body of compelling clinical results by NIH investigators and peer companies," said Ian McNiece, Ph.D., BioCardias Chief Scientific Officer. "After IV delivery, the cells migrate to the lungs for local therapeutic benefit. We expect the anti-inflammatory nature of these mesenchymal stem cells to have a positive impact in ARDS because of the interaction of the Neurokinin-1 receptors with Substance P, a neuropeptide that has long been known to be a primary mediator of inflammation in the lungs. Our goal is to help recovering patients with ARDS due to COVID-19 recover faster and more fully, while avoiding longer term respiratory issues."

"In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA's acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and validation for its potential to provide therapeutic benefit beyond the cardiovascular system," said Peter Altman, Ph.D., Chief Executive Officer. "Our off the shelf MSC platform may have significant advantages over others in clinical development for multiple indications because the MSCs express the biologically important NK1 receptor which binds Substance P. Our in-house clinical cell manufacturing is also expected to be an important strategic asset that enables rapid and cost-effective development."

About ARDS

Acute respiratory distress syndrome (ARDS) occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. The fluid keeps the lungs from filling with enough air, which means less oxygen reaches the bloodstream. This deprives organs of the oxygen they need to function. ARDS typically occurs in people who are already critically ill or who have significant injuries. Severe shortness of breath the main symptom of ARDS usually develops within a few hours to a few days after the precipitating injury or infection. Many people who develop ARDS don't survive. The risk of death increases with age and severity of illness. Of the people who do survive ARDS, some recover completely while others experience lasting damage to their lungs1. Based on preliminary clinical reports on COVID-19, respiratory failure complicated by ARDs is the leading cause of death for COVID-19 patients.2 Despite multiple clinical studies, no pharmacological treatments have proven effective for ARDS.3, 4

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Companys biotherapeutic platforms that enable four product candidates in clinical development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS reimbursement. For more information visit:www.BioCardia.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, initiation of our BCDA-04 clinical trial, and the mechanism of action and ease of administration of our NK1R+ MSC therapy.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on March 29, 2022, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

_________________________________________________________________________________________________________

Media Contact:Anne Laluc, MarketingEmail:alaluc@BioCardia.comPhone: 650-226-0120

Investor Contact:David McClung, Chief Financial OfficerEmail:dmcclung@BioCardia.comPhone: 650-226-0120

(1)MayoClinic.Org

(2)Rajagopal K, Keller SP, Akkanti B, et al. Advanced pulmonary and cardiac support of COVID-19 patients, emerging recommendations from ASAIOa living working document. Circ Heart Fail. 2020 May;13(5).

(3)Thompson BT, Chambers RC, Liu KD (2017) Acute respiratory distress syndrome. N Engl J Med 377(19):19041905.

(4)3. Group RC, Horby P, Lim WS et al (2020) Dexamethasone in hospitalized patients with Covid-19preliminary report. N Engl J Med.

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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress...

Cardiac Stem Cells Comments Off on BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress… | April 15th, 2022

April 9 (Reuters) - The first all-private team of astronauts ever launched to the International Space Station (ISS) were welcomed aboard the orbiting research platform on Saturday to begin a weeklong science mission hailed as a milestone in commercial spaceflight.

Their arrival came about 21 hours after the four-man team representing Houston-based startup company Axiom Space Inc lifted off on Friday from NASA's Kennedy Space Center, riding atop a SpaceX-launched Falcon 9 rocket.

The Crew Dragon capsule lofted into orbit by the rocket docked with the ISS at about 8:30 a.m. EDT (1230 GMT) on Saturday as the two space vehicles were flying roughly 250 miles (420 km) above the central Atlantic Ocean, a live webcast of the coupling from the National Aeronautics and Space Administration showed.

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The final approach was delayed for about 45 minutes by a technical glitch with a video feed used to monitor the capsule's rendezvous with the ISS, but it otherwise proceeded smoothly.

The multinational Axiom team, planning to spend eight days in orbit, was led by retired Spanish-born NASA astronaut Michael Lopez-Alegria, 63, the company's vice president for business development.

His second-in-command was Larry Connor, a real estate and technology entrepreneur and aerobatics aviator from Ohio designated as the mission pilot. Connor is in his 70s, but the company did not provide his precise age.

Rounding out the Ax-1 crew were investor-philanthropist and former Israeli fighter pilot Eytan Stibbe, 64, and Canadian businessman and philanthropist Mark Pathy, 52, both serving as mission specialists.

With docking achieved, it took nearly two hours for the sealed passageway between the space station and crew capsule to be pressurized and checked for leaks before hatches were opened to allow the newly arrived astronauts to come aboard the ISS.

The Ax-1 team was welcomed by all seven of the regular, government-paid crew members already occupying the space station: three American astronauts, a German astronaut from the European Space Agency and three Russian cosmonauts.

The NASA webcast showed the four smiling Axiom astronauts, dressed in navy blue flight suits, floating headfirst, one by one, through the portal into the space station, warmly greeted with hugs and handshakes by the ISS crew.

Lopez-Alegria later pinned astronaut wings onto the uniforms of the three spaceflight rookies of his Axiom team -- Connor, Stibbe and Pathy -- during a brief welcome ceremony.

Stibbe is now the second Israeli to fly to space, after Ilan Ramon, who perished with six NASA crewmates in the 2003 space shuttle Columbia disaster.

SCIENCE FOCUSED

The new arrivals brought with them two dozen science and biomedical experiments to conduct aboard ISS, including research on brain health, cardiac stem cells, cancer and aging, as well as a technology demonstration to produce optics using the surface tension of fluids in microgravity.

The mission, a collaboration among Axiom, Elon Musk's rocket company SpaceX and NASA, has been touted by all three as a major step in the expansion of space-based commercial activities collectively referred to by insiders as the low-Earth orbit economy, or "LEO economy" for short. read more

NASA officials say the trend will help the U.S. space agency focus more of its resources on big-science exploration, including its Artemis program to send humans back to the moon and ultimately to Mars.

While the space station has hosted civilian visitors from time to time, the Ax-1 mission marks the first all-commercial team of astronauts sent to ISS for its intended purpose as an orbiting research laboratory.

The Axiom mission also stands as SpaceX's sixth human spaceflight in nearly two years, following four NASA astronaut missions to the space station and the Inspiration 4 launch in September that sent an all-civilian crew into orbit for the first time. That flight did not dock with the ISS.

Axiom executives say their astronaut ventures and plans to build a private space station in Earth orbit go far beyond the astro-tourism services offered to wealthy thrill-seekers by such companies as Blue Origin and Virgin Galactic (SPCE.N), owned respectively by billionaire entrepreneurs Jeff Bezos and Richard Branson.

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Reporting by Steve Gorman in Los Angeles; Editing by Angus MacSwan, Daniel Wallis and Jonathan Oatis

Our Standards: The Thomson Reuters Trust Principles.

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Space station's first all-private astronaut team welcomed aboard orbiting platform - Reuters

Cardiac Stem Cells Comments Off on Space station’s first all-private astronaut team welcomed aboard orbiting platform – Reuters | April 15th, 2022

Early findings from the phase 1/2a TEM-GBM study presented at the 2022 AACR Annual Meeting displayed potential of temferon to affect the tumor microenvironment of glioblastoma.

Immune system activation and tumor microenvironment alteration were effects observed in patients with glioblastoma treatment with temferon, a genetically modified Tie2-expressing monocyte (TEM) targeting interferon-2 (IFN2), according to early findings of the phase 1/2a TEM-GBM study (NCT03866109) presented in a poster at the American Association for Cancer Research (AACR) 2022 Annual Meeting.

These results provide the initial evidence for on-target activity of Temferon in GBM, said Bernard Gentner, MD, study coauthor and the leader of the translational stem cell and leukemia research unit at San Raffaele Telethon Institute for Gene Therapy in Milan, Italy.

Temferon is an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector, driving myeloid-specific IFN2 expression. Genetically modified TEMs target IFN2 expression in the GBM tumor microenvironment.

In order to guarantee stable delivery of genetically engineered TEMs into the tumor, we transduce hematopoietic stem and progenitor cells with a lentiviral vector carrying the IFNa2 transgene transcriptionally regulated by the Tie2 promoter and by post transcriptional elements that guarantee that the transgene is expressed only in myeloid cells that are recruited into the tumor, Gentner said.

TEM-GBM is an open-label, dose-escalation study evaluating the safety and efficacy of Temferon in up to 21 newly diagnosed patients with GBM harboring an unmethylated MGMT promoter. Following surgical resection, up to 15 patients were assigned to 1 of 3 escalating doses of Temferon and 1 of 2 different conditioning regimens in part A of the trial. In Part B, 6 more patients will receive a single dose of Temferon at the recommended phase 2 dose.

Following completion of radiotherapy, patients received a conditioning regimen consisting of carmustine (BCNU) and thiotepa (Tepadina) in cohorts 1 to 4 or busulfan (Busulfex) and thiotepa in cohort 5 prior to administration of Temferon.

In-patient monitoring occurs until hematological recovery, then patients will undergo regular follow-up for up to 720 days. At that point, patients are invited to participate in a long term follow-up study for an additional 6 years.

Eligible adults aged 18 to 70 years must have an ECOG performance score of 0 to 1, a Karnofsky performance score greater than 70%, and adequate cardiac, renal, hepatic, and pulmonary function. Patients with active autoimmune disease or who have received any oral or parenteral chemotherapy or immunotherapy within 2 years of screening are excluded.

The primary end points of the study are Temferon engraftment over the first 90 days, proportion of patients achieving hematologic recovery 30 days after autologous stem cell transplantation, and short-term tolerability of Temferon as defined by stable blood counts, absence of cytopenias, absence of significant organ toxicities greater than grade 2, and absence of Replication Competent Lentivirus.

By the October 15, 2021, data cutoff, the median follow-up was 267 days (range: 60-749). Patients in cohorts 1 to 3 received a dose 0.5-2.0 x 106/kg Temferon with an average vector copy number of 0.70 and a transduction efficiency of 54%. Those in cohorts 4 and 5 received 2.0 x 106/kg Temferon with an average vector copy number of 0.77 and a transduction efficiency of 49%.

Investigators observed increasing proportions of Temferon-derived differentiated cells, as determined by the presence of vector genomes in the DNA of peripheral blood and bone marrow cells, reaching up to 30% at 1 month in the highest treatment cohort (2.0 x 106/kg). Those differentiated cells persisted at lower levels for up to 18 months.

All patients showed in vivo Temferon engraftment, Gentner said. Engraftment was highest at 1 month, and in many patients resembled pretty much the input fraction. Engraftment then decreased, stabilizing at 3 to 6 months around 10%.

Despite the significant proportion of engineered cells, only very low-medium concentrations of interferon alpha were detected in the plasma and in the cerebral spinal fluid, indicating a tight regulation of the vector expression.

Gentner added that Temferon did not delay hemopoietic recovery, and neutrophil and platelet engraftment were similar to standard autologous stem cell procedure.

Investigators did not detect any dose limiting toxicities. Gentner said that, so far, adverse events have been related to progression or the transplant procedure, not to the IFN2 itself.

Gentner B, Finocchiaro G, Farina F, et al. Genetically modified Tie-2 expressing monocytes target IFN-2 to the glioblastoma tumor microenvironment (TME): Preliminary data from the TEM-GBM Phase 1/2a study. Poster presented at: 2022 AACR Annual Meeting; April 8-13, 2022; New Orleans, LA. Abstract 5213.

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Evidence Shows Novel Temferon May Have Activity in Glioblastoma - Cancer Network

Cardiac Stem Cells Comments Off on Evidence Shows Novel Temferon May Have Activity in Glioblastoma – Cancer Network | April 15th, 2022

Courtesy of Pavlo Gonchar/SOPA Images/LightRocket via Getty Images

Drug pricing watchdog ICER, the Institute for Clinical and Economic Review, issued a draft report on bluebird bios gene therapy betibeglogene autotemcel for beta-thalassemia. Despite the proposed price tag of $2.1 million, ICERs not-yet-finalized report supports the therapys cost-effectiveness. This is good news for the recently beleaguered company.

Gene therapies are typically designed to cure a disease by replacing or fixing a damaged gene. Bluebirds therapy, which is listed under the brand name Zynteglo, had been approved in Europe and the UK, where its price is around $1.7 million (U.S.). However, the company pulled the therapy off the market in Europe over what it called a hostile pricing and reimbursement environment.

On April 5, bluebird bio announced it was beginning a comprehensive restructuring in hopes of cutting $160 million in costs over the next two years. It planned to re-focus on near-term catalysts, which include Zynteglo in the U.S., gene therapy for cerebral adrenoleukodystrophy (eli-cel) and a potential biologics license application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease. The BLA application is planned for 2023, while the U.S. regulatory decisions are expected this year. The PDUFA date for Zynteglo is Aug.19, 2022, and Sept. 16, 2022, for eli-cel.

As part of the restructuring, the company is cutting its workforce by about 30%.

ICER recommendations arent binding, but they have influence. If ICER says a drug is overpriced, it provides ammunition for payers, such as Medicare and insurers, to push back against proposed prices.

Gene therapies are very expensive. For example,Novartis Zolgensma, the one-time gene therapy onasemnogene abeparvovec for spinal muscular atrophy (SMA), is generally viewed as the most expensive drug with a price tag of $2.1 million. On the other hand, as an apparent cure for a disease that kills children by the age of two, it is very rare. The argument for these therapies, aside from their curative potential for otherwise incurable diseases, is that over the life of the patient, they are cost-effective.

Novartis and Spark Therapeuticss gene therapy Luxturna (voretigene neparvovec) runs about $850,000 per patient in the U.S. The therapy is for inherited retinal dystrophy with RPE65 mutations. It is typically diagnosed in childhood and eventually causes almost total blindness, and the therapy is essentially a cure.

Beta thalassemia is a genetic disease that impairs the ability of red blood cells to manufacture hemoglobin, the molecule in the body that carries oxygen. There are about 40,000 newly diagnosed cases in children each year around the world. People with the most severe form of it develop life-threatening anemia around four to six months of age and have to receive monthly blood transfusions and other treatments, such as iron-chelating drugs. The only other potential cure is hematopoietic stem cell transplantation (HSCT) but requires a donor with a matching human leukocyte antigen (HLA) profile within the appropriate age range.

Bluebirds Zynteglo appears to be another option for a cure, although how long the therapys effects last is something of an open question. The ICER report noted the uncertainties, but concluded that the evidence suggests that beti-cel provides net health benefits to patients with TDT.

The ICER report indicated, per Managed Healthcare Executive, that "patients could be treated without reaching the potential budget impact threshold at three prices (about $1.85 million, $2.11 million and $2.38 million per course of treatment). This analysis was done at several prices to document the percentage of patients who could be treated without crossing a potential budget impact threshold that is aligned with the overall growth in the U.S. economy.

In Phase III trials, 89% of patients who received the therapy became transfusion independent, and in Phase I/II and III trials, those patients remained transfusion-free for at least 42 months. In general, side effects were mild and no deaths were reported. In December 2021, bluebird presented data at the American Society of Hematology meeting from a long-term study (LTF-303) that showed adult and pediatric patients with beta-thalassemia who required regular red blood cell transfusions can produce normal or near-normal levels of total hemoglobin and remain transfusion-free with stable iron markers up to seven years after receiving beti-cel.

A 2017 study published in Blood found that on average, beta-thalassemia patients required 17 transfusions per year, 23 days apart. Mean total healthcare costs for the patients were $128,062, plus or minus $62,260 per year. Total costs were primarily driven by chelation and transfusion costs.

Although the severity of the disease varies, a 2009 study found that people with beta-thalassemia major often die from cardiac complications of iron overload by 30 years of age," making bluebird's new therapy, if it is successful, vital for these patients.

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Drug Price Watchdog Calls Bluebird Bio's $2.1 Million Gene Therapy Cost-Effective - BioSpace

Cardiac Stem Cells Comments Off on Drug Price Watchdog Calls Bluebird Bio’s $2.1 Million Gene Therapy Cost-Effective – BioSpace | April 15th, 2022

The addition of the innate cell engager AMF13 to preactivated and expanded natural killer (NK) cells may represent an effective treatment for pretreated patients with advanced lymphoma, according to findings from a phase 1/2 study (NCT04074746) that were presented during the 2022 AACR Annual Meeting. 1

Results showed that patients experienced a median overall response rate (ORR) of 89.5% (n = 17/19). Overall, 10 patients experienced complete responses (CRs) and 7 experienced partial responses (PRs).2

Lead author Yago Nieto, MD, PhD, a professor of medicine in the Department of Stem Cell Transplantation and Cellular Therapy at the University of Texas MD Anderson Cancer Center, in Houston, discussed the findings during a press conference during the meeting. He said the study team was pleasantly surprised by the quality of tumor responses in patients with resistant lymphomas.

This is the first clinical trial using off the shelf cord blood-derived cytokine-induced memory-likeex vivoexpanded NK cells precomplexed with the innate cell engager AMF13 construct to treat patients with CD30-positive relapsed/refractory Hodgkin lymphoma, he said. We saw very encouraging activity in this population of very heavily pretreated patients.

The current standard of care for relapsed CD30-positive lymphomas is brentuximab vedotin (Adcetris), an antibody-drug conjugate that delivers a toxic cytoskeleton destabilizing agent to cells expressing CD30. However, not all these lymphomas respond to brentuximab vedotin. When that treatment fails, those tumors then become extremely resistant to killing and patients are left with very few effective therapeutic options.

To address the problem, investigators enrolled 22 patients with relapsed or refractory CD30+ lymphoma into this single-center phase 1/2 trial, 20 of whom were diagnosed with Hodgkin lymphoma (HL). All had active progressive disease at enrollment, and none received bridging therapy. Patients were heavily pretreated, with a median of 7 (range, 1-14) prior lines of therapy. Nine underwent autologous stem cell transplantation (SCT) and 5 received allogeneic SCT.

Eligible patients had relapsed/refractory CD30-positive classical HL, B-cell non-Hodgkin lymphoma, anaplastic large-cell lymphoma, or peripheral T-cell lymphoma that was refractory or intolerant to brentuximab vedotin. They needed to have an ECOG performance status of 2 or below, and adequate renal, hepatic, pulmonary, and cardiac function.

The median age was 40 years (range, 20-75). Most patients were white (68.2%) and male 68.1%).

Patients receive 2 cycles of fludarabine/cyclophosphamide, followed by AFM13-CB NK cells at 3 dose levelsDL1 (106NK/gg), DL2 (107NK/kg), and DL3 (108NK/kg)on day 0 plus 3 weekly intravenous infusions of 200 mg AFM13, a CD30/CD16A bispecific antibody. Nineteen patients completed both planned cycles of treatment.

Nieto and colleagues isolated NK cells from cord blood, then used a mixture of cytokines to activate the cells into a memory-like state, making them more persistent and effective. They then expanded the cells in culture and complexed them with AFM13.

At a median follow-up of 11 months, progression-free survival (PFS) and overall survival (OS) rates across all 3 dose levels were 52% and 81%, respectively. Across all dose levels, 53% of patients experienced CR and 37% had PR. Eleven percent had progressive disease.

Expansion of NK cells occurred immediately after infusion and persisted for 3 weeks.

Investigators established DL3 as the recommend phase 2 dose (RP2D). All 13 (100%) patients treated at this dose level responded to therapy, including eight CRs (62%).Five of those patients were in CR after cycle 1, and 3 additional patients converted from PR to CR after cycle 2, Nieto added.

The median PFS was 67% and the median OS was 93% in the RP2D population.

Investigators did not record any cytokine release syndrome or graft vs host disease (GVHD), or neurotoxicity. Our preliminary results show an excellent tolerability profile, Nieto said.

There was no instance of infusion-related reactions (IRRs) associated with AFM13-NK cells across 40 infusions. There was 1 instance of grade 3 IRR and 4 grade 2 IRRs in 108 infusions of AFM13 alone. Investigators observed no dose limiting toxicities.

Never before in mankind have we seen this approach, really leading to pretty staggering results, Timothy Yap, MBBS, PhD, FRCP, a medical oncologist and associate director of translational research in the Institute for Personalized Cancer Therapy at the University of Texas MD Anderson Cancer Center, said. Everyone can see for themselves how impressive these results are. In addition to that, the actual tolerability profile is truly excellent with no instances of cytokine release syndrome, no neurotoxicity, no GVHD. Truly, truly impressive.

References

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Adding Bispecific Antibody to Natural Killer Cells May Be Effective in Heavily Pretreated Lymphoma - http://www.oncnursingnews.com/

Cardiac Stem Cells Comments Off on Adding Bispecific Antibody to Natural Killer Cells May Be Effective in Heavily Pretreated Lymphoma – www.oncnursingnews.com/ | April 15th, 2022

The use of human bone marrow mesenchymal stem cells (hBMSCs) to regenerate and repair bone tissue defects is a complex research field of bone tissue engineering; nevertheless, it is a hot topic. One of the biggest problems is the limited survival and osteogenic capacity of the transplanted cells within the host tissue. Even for hBMSCs with their low immunogenicity, the body will still cause a local immune-inflammatory response directed against the allogeneic cells and thereby reduce the activity of the transplanted cells. Even in the case of successful transplantation, the lack of vascularization at the transplantation site makes it difficult for the transplanted cells to exchange nutrients and metabolic wastes that ultimately affects bone regeneration. In this study, we covalently modified alginate with RGD and QK peptides that were injected subcutaneously into immunocompetent mice. Histological analysis, as well as ELISA techniques, proved that this method is able to provide bioactive stem cell transplant beds containing functionalized biomaterials and vascularized surrounding tissues. Inflammation-related factors, such as IL-2, IL-6, TNF-, and IFN-, around the cell graft beds decreased with time and were lowest at the second week. Then, the hBMSCs were injected into the cell transplantation beds intended to form vascularized bonelike tissues that were evaluated by micro-computed tomography (Micro CT), histological, and immunohistochemical analyses. The results showed that the expression of osteogenesis-related proteins RUNX2, COL1A1, and OPN, as well as the expression of angiogenic factor vWF and cartilage-related protein COL2A1 were significantly upregulated in the hBMSC-derived osteogenic tissue. These results suggest that the stem cell transplantation strategy by constructing bioactive cell transplant beds is effective to enhance the bone regeneration capacity of hBMSCs and holds great potential in bone tissue engineering.

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Strategy of Stem Cell Transplantation for Bone Regeneration with Functionalized Biomaterials and Vascularized Tissues in Immunocompetent Mice -...

Bone Marrow Stem Cells Comments Off on Strategy of Stem Cell Transplantation for Bone Regeneration with Functionalized Biomaterials and Vascularized Tissues in Immunocompetent Mice -… | April 3rd, 2022

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A breakthrough made by Australian researchers might change the way doctors treat a broken or missing bone. Turns out stem cells can turn into bone if certain conditions are met.

Normally, bone can be made only of mesenchymal stem cells (MSCs) which are biologically found in the bone marrow.

Extracting them from there is a difficult and painful procedure while doing so at scale is beyond tricky.

But this could change any moment now after Australian researchers found that stem cells can be converted into bone when a certain type of sound waves are used.

Tests had previously shown that low frequency vibrations were great at inducing cell differentiation but the process took over a week and the results were mixed at best.

Nobody had bothered to look into high frequency sound waves until now. RMIT researchers took a microchip capable of dispersing sound waves in the Mhz range and turned it at MSCs in silicon oil on a culture plate.

The team noticed that after exposing the cells to 10MhZ signals for 10 minutes daily for five days, the markers indicating the bone conversion appeared.

We can use the sound waves to apply just the right amount of pressure in the right places to the stem cells, to trigger the change process, said Leslie Yeo, co-lead researcher on the study. Our device is cheap and simple to use, so could easily be upscaled for treating large numbers of cells simultaneously vital for effective tissue engineering.

This discovery, detailed in the journalSmall, eliminates the need of drugs to make stem cells behave this way. Moreover, the MSCs can be pulled from a variety of places, like fast tissue, not just bone marrow.

By injecting them into the body in case of an injury or disease, they can start working on a new bone faster and more efficient.

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Stem Cells Turn Into Bone When Sound Waves Are Near - TechTheLead

Bone Marrow Stem Cells Comments Off on Stem Cells Turn Into Bone When Sound Waves Are Near – TechTheLead | April 3rd, 2022

Jasper Therapeutics

REDWOOD CITY, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (NASDAQ: JSPR), a biotechnology company focused on hematopoietic cell transplant therapies, today announced that updated data from the Companys ongoing study of JSP191 as single agent conditioning prior to allogeneic hematopoietic stem cell (HSC) re-transplant in patients with severe combined immunodeficiency (SCID) has been accepted for presentation as a late-breaking poster at the 2022 Clinical Immunology Society (CIS) Annual Meeting, to be held in Charlotte, North Carolina from March 31 to April 3, 2022.

Title: Update: Single-Agent Conditioning with Anti-CD117 Antibody JSP191 Shows Donor Engraftment, Nave Lymphocyte Production, and Clinical Benefit in Patients with Severe Combined Immunodeficiency (SCID)Date and Time: Friday, April 1, 2022, 1:00-2:00 p.m. ET

This updated data indicates that JSP191 at 0.6mg/kg can deplete blood stem cells, leading to long-term donor cell engraftment, immune reconstitution which positively affects the clinical status of SCID patients who suffer from poor T cell and negligible B cell immunity because they failed their first transplant, said Wendy Pang, MD, Ph.D., Senior Vice President of Research and Translational Medicine of Jasper Therapeutics. This population of SCID patients is largely without treatment options and rely on supportive therapies like life long IVIG to provide some level of immune protection. JSP191 based conditioning may provide these patients with the best chance of a safe and successful transplant and reconstituted immune system.

CIS attendees are the primary caregivers for the immune deficient patient population, we are pleased to be able to present this data at the 2022 CIS annual meeting, Ronald Martell, CEO of Jasper. We believe that with our successful clinical efforts, we are one step closer, and uniquely positioned to deliver a targeted non-genotoxic conditioning agent to patients with SCID.

Story continues

About JSP191

JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or genetically modified transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 100 healthy volunteers and patients. Three clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML), severe combined immunodeficiency (SCID) and Fanconi anemia are currently enrolling. The Company plans a new study of JSP191 as a second-line therapeutic in lower risk MDS patients in 2022 as well as to a pivotal study in MDS/AML transplant in early 2023. Enrollment in additional studies are planned in patients with sickle cell disease, chronic granulomatous disease and GATA2 MDS who are undergoing hematopoietic cell transplantation.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic hematopoietic cell transplants and gene therapies. In parallel, Jasper Therapeutics is advancing its preclinical mRNA engineered hematopoietic stem cell (eHSC) platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential long-term benefits of hematopoietic stem cells (HSC) engraftment following targeted single-agent JSP191 conditioning in the treatment of severe combined immunodeficiency (SCID) and Jaspers ability to potentially deliver a targeted non-genotoxic conditioning agent to patients with SCID. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jaspers product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that Jaspers product candidates may not be beneficial to patients or successfully commercialized; patients willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jaspers business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jaspers business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jaspers filings with the SEC. If any of these risks materialize or Jaspers assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jaspers assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:John Mullaly (investors)LifeSci Advisors617-429-3548jmullaly@lifesciadvisors.com

Jeet Mahal (investors)Jasper Therapeutics650-549-1403jmahal@jaspertherapeutics.com

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Jasper Therapeutics to Present Updated Data on JSP191 Conditioning in SCID Patients at the 2022 Clinical Immunology Society Annual Meeting - Yahoo...

Bone Marrow Stem Cells Comments Off on Jasper Therapeutics to Present Updated Data on JSP191 Conditioning in SCID Patients at the 2022 Clinical Immunology Society Annual Meeting – Yahoo… | April 3rd, 2022

Prophecy Market Research delivered a business report on the Rheumatoid Arthritis Stem Cell Therapy which is the best creation of trust and skill. The report is a top to bottom assessment of the different attributes and future development possibilities during the figure time frame. To uncover every doable way, our examiners applied different strategies. It contains every one of the overall significant organizations to help our clients in understanding their thorough strategies and cutthroat climate.

The noticeable players in the worldwide Rheumatoid Arthritis Stem Cell Therapy are

Mesoblast Ltd., Roslin Cells, Regeneus Ltd, ReNeuron Group plc, International Stem Cell Corporation, TiGenix and others

Our investigator have partitioned the report into segments so you might become familiar with the overall market undiscovered possibility in every one.

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The market elements are analyzed inside and out in the outline segment. This part is an unquestionable requirement perused for anybody settling on information driven choices. It talks about how Rheumatoid Arthritis Stem Cell Therapy functions, as well as market size and volume. The report is coordinated in straightforward organizations and incorporates outlines, tables, and charts to inspect the information and uncover the secret example in the numbers. Besides, the report incorporates verifiable deals and income data as well as guage designs for the following not many years.

The development and limiting elements are given their own fragment to help our clients in observing the Rheumatoid Arthritis Stem Cell Therapy touch spots and problem areas. The ends attracted this part depend on trustworthy and more significant position sources. Our specialists have utilized an assortment of market projection ways to deal with furnish our clients with reliable outcomes.

The Rheumatoid Arthritis Stem Cell Therapy is isolated into different groupings in the division segment. The fragment is an inside and out assessment of every classification, which is grouped by its qualities and expansiveness. Weve recorded every one of the measurements along with subjective clarifications to assist clients with appreciating the expected broadness of each class before very long. To dispose of errors in current realities and discoveries, the report utilizes an assortment of measurable methodologies. Moreover, an assortment of pattern projection approaches are utilized to uncover future development angles and prospects.

By Product Type (Allogeneic Mesenchymal Stem Cells, Bone Marrow Transplant and Adipose Tissue Stem Cells)

By End-User (Hospitals, Ambulatory Surgical Centers and Specialty Clinics)

By Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

Mesoblast Ltd., Roslin Cells, Regeneus Ltd, ReNeuron Group plc, International Stem Cell Corporation, TiGenix and others

Promising Regions & Countries Mentioned In The Rheumatoid Arthritis Stem Cell Therapy Report:

The local review area inspects all potential market scenes in specific areas before very long. Its an exhaustive assessment of the Rheumatoid Arthritis Stem Cell Therapy possible districts. The examination additionally remembers a contextual investigation for significant market members to help shoppers distinguish and understand powerful techniques in the overall Rheumatoid Arthritis Stem Cell Therapy , as well as likely boundaries. Our master experts checked the data and endeavored to protect the most ideal degree of exactness.

Segmentation Overview:

By Product Type (Allogeneic Mesenchymal Stem Cells, Bone Marrow Transplant and Adipose Tissue Stem Cells)

By End-User (Hospitals, Ambulatory Surgical Centers and Specialty Clinics)

By Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

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Rheumatoid Arthritis Stem Cell Therapy Market Assessment, With Major Top Companies Analysis, Geographic Analysis, Growing Opportunities Data By...

Bone Marrow Stem Cells Comments Off on Rheumatoid Arthritis Stem Cell Therapy Market Assessment, With Major Top Companies Analysis, Geographic Analysis, Growing Opportunities Data By… | April 3rd, 2022

This article was originally published here

Bioengineered. 2022 Apr;13(4):8382-8395. doi: 10.1080/21655979.2022.2036891.

ABSTRACT

The exosomes (Exo) had always been considered as transport vectors for microRNA (miRNA). An increasing number of data had clarified the influence of Exo on the cell progression of non-small cell lung cancer (NSCLC). Nevertheless, its specific mechanism had not yet been verified. This work was to explore the potential mechanism of Exo-derived miR-631 targeting and regulating E2F family of transcription factor 2 (E2F2) to repress the malignant behavior of NSCLC cells. Test of microRNA (miR)-631 and E2F2 in NSCLC was performed. BMSCs-Exo that altered miR-631 was co-cultured with NSCLC cells. Detection of the cloning and progression of NSCLC cells was performed. Testification of the targeting of miR-631 with E2F2 was conducted. In vivo experiments were performed to verify the results in vitro. In short, elevation of miR-631 Exo repressed the advancement and phosphatidylinositol 3-kinase/Akt activation of NSCLC cells, while silence of miR-631 was in the opposite. In terms of mechanism, miR-631 exerted the influence via targeting E2F2. The coincident results were obtained in animal models. In brief, BMSC-Exo mediated E2F2 via delivering miR-631 to NSCLC cells to modulate the malignant behavior of NSCLC.

PMID:35353027 | DOI:10.1080/21655979.2022.2036891

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MicroRNA-631 deriving from bone marrow mesenchymal stem cell exosomes facilitates the malignant behavior of non-small cell lung cancer via modulating...

Bone Marrow Stem Cells Comments Off on MicroRNA-631 deriving from bone marrow mesenchymal stem cell exosomes facilitates the malignant behavior of non-small cell lung cancer via modulating… | April 3rd, 2022

Abstract:

Background:

Objective:To observe the effect of H2O2 induced oxidative stress on autophagy and apoptosis of human bone marrow mesenchymal stem cells (hBMSCs).

Method: The hBMSCs were separated and cultured by density gradient centrifugation combined with adherence method. They were divided into blank group (with medium only), 3-MA (autophagy inhibitor) pretreatment group (with 2 ml of 5 mM 3-MA medium), H2O2 Intervention group (add 2ml medium containing 0.05mM H2O2), H2O2+3-MA treatment group (add 2ml medium containing 5mM 3-MA, then add 2ml medium containing 0.05mM H2O2). DCFH-DA staining was used to detect cellular reactive oxygen species (ROS) levels,and CCK-8 analysis was used to detect the effects of different concentrations (0,50,100,200,400mol/L) of H2O2 on the proliferation of hBMSCs; Monodansylcadaverine(MDC) Fluorescent amine probe staining, Lysosome Red Fluorescent Probe (Lyso-Tracker Red) staining to observe the level of autophagy; Immunofluorescence staining to detect the expression of LC3A/B; Flow cytometry (Annexin V/PI) to detect cell apoptosis Circumstances; Protein chip detection of autophagy-related proteins; Western blot detection of Beclin1, mTOR, p-mTOR, LC3A/B, and Cleaved caspase-3 protein expression.

Result: After treating hBMSCs with different concentrations of H2O2 (0,50,100,200,400mol) for 24h ,48h, and 72h, with the increase of H2O2 concentration, the cell proliferation ability decreased; while with the extension of time, the cell proliferation ability increased not significantly; 50mol cell proliferation ability is the strongest. Compared with the blank group and 3-MA group, the H2O2 intervention group increased the level of intracellular ROS, increased autophagosomes, and significantly decreased the apoptosis rate; up-regulated Beclin1, mTOR, LC3A/B and Cleaved caspase-3 protein expression, and down-regulated p-mTOR Protein expression level. Compared with the autophagy inhibitor 3-MA group, the H2O2+3-MA group increased the level of intracellular ROS, increased autophagosomes, and did not significantly increase the apoptosis rate; up-regulated the protein expression of Beclin1, mTOR, LC3A/B and Cleaved caspase-3 Down-regulate the expression of p-mTOR protein.

Conclusion: H2O2 can induce hMSCs to produce oxidative stress response. Under oxidative stress conditions, hMSCs can promote protective autophagy and reduce cell apoptosis or the level of apoptosis caused by excessive autophagy.

See more here:
Effect of oxidative stress-induced autophagy on proliferation and apoptosis of hMSCs - Newswise

Bone Marrow Stem Cells Comments Off on Effect of oxidative stress-induced autophagy on proliferation and apoptosis of hMSCs – Newswise | April 3rd, 2022

The latest study of the Personalized Cell Therapy MarketStatistics2022Report providesan elaborative analysis of the market size, industry share, growth, development, and competitive landscape. The report also provides a comprehensive analysis of the sales volume, revenue, gross margin, and price growth in the Personalized Cell TherapyMarket. Many key points covered in the report, include recent development in the global market, such as mergers and acquisitions, SWOT analysis, competitive landscape, industry trends, and company profiles.

Leading Key Players Covered in the GlobalPersonalized Cell Therapy Market Research Report:

Novartis AG, Vericel Corporation, Bellicum Pharmaceuticals, MolMed SpA, Cytori Therapeutics Inc, Gilead Sciences, Inc, Celgene Corporation, Bluebird Bio, Aurora Biopharma Inc, Saneron CCEL TherapeuticsInc, Kuur Therapeutics, MediGene AG, Sangamo Therapeutics

Get a Sample PDF of the Report @ https://www.alexareports.com/report-sample/2856089

Market Segment by Types:

By Cell Type, Hematopoietic Stem Cell, Skeletal Muscle Stem Cell/Mesenchymal Stem Cells/Lymphocytes, By Technique, Platelet Transfusions/Bone Marrow Transplantation/Packed Red Cell Transfusions/Organ Transplantation

Market Segment by Applications:

Cardiovascular Diseases, Neurological Disorders, Inflammatory Diseases, Diabetes, Cancer

Market Segment by Regions:

Table of Contents

Section 1 Personalized Cell Therapy Market Overview

Section 2 Global Personalized Cell Therapy Market Key Players Share

Section 3 Key PlayersPersonalized Cell Therapy Business Introduction

Section 4 Global Personalized Cell Therapy Market Segmentation (By Region)

Section 5 Global Personalized Cell Therapy Market Segmentation (by Product Type)

Section 6 Global Personalized Cell Therapy Market Segmentation (by Application)

Section 7 Global Personalized Cell Therapy Market Segmentation (by Channel)

Section 8 Personalized Cell Therapy Market Forecast 2021-2026

Section 9 Personalized Cell Therapy Application and Client Analysis

Section 10 Personalized Cell Therapy Manufacturing Cost of Analysis

Section 11 Conclusion

Section 12 Methodology and Data Source

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Personalized Cell Therapy Market Size by Applications, Company Profiles, Product Types, Revenue and Forecast to 2026 ChattTenn Sports - ChattTenn...

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The SARS-CoV-2 virus can infect specialized pacemaker cells that maintain the hearts rhythmic beat, setting off a self-destruction process within the cells, according to a preclinical study co-led by researchers at Weill Cornell Medicine, NewYork-Presbyterian and NYU Grossman School of Medicine. The findings offer a possible explanation for the heart arrhythmias that are commonly observed in patients with SARS-CoV-2 infection.

In the study, reported March 8 in Circulation Research, the researchers used an animal model as well as human stem cell-derived pacemaker cells to show that SARS-CoV-2 can readily infect pacemaker cells and trigger a process called ferroptosis, in which the cells self-destruct but also produce reactive oxygen molecules that can impact nearby cells.

This is a surprising and apparently unique vulnerability of these cellswe looked at a variety of other human cell types that can be infected by SARS-CoV-2, including even heart muscle cells, but found signs of ferroptosis only in the pacemaker cells, said study co-senior author Dr. Shuibing Chen, the Kilts Family Professor of Surgery and a professor of chemical biology in surgery and of chemical biology in biochemistry at Weill Cornell Medicine.

Arrhythmias including too-quick (tachycardia) and too-slow (bradycardia) heart rhythms have been noted among many COVID-19 patients, and multiple studies have linked these abnormal rhythms to worse COVID-19 outcomes. How SARS-CoV-2 infection could cause such arrhythmias has been unclear, though.

In the new study, the researchers, including co-senior author Dr. Benjamin tenOever of NYU Grossman School of Medicine, examined golden hamstersone of the only lab animals that reliably develops COVID-19-like signs from SARS-CoV-2 infectionand found evidence that following nasal exposure the virus can infect the cells of the natural cardiac pacemaker unit, known as the sinoatrial node.

To study SARS-CoV-2s effects on pacemaker cells in more detail and with human cells, the researchers used advanced stem cell techniques to induce human embryonic stem cells to mature into cells closely resembling sinoatrial node cells. They showed that these induced human pacemaker cells express the receptor ACE2 and other factors SARS-CoV-2 uses to get into cells and are readily infected by SARS-CoV-2. The researchers also observed large increases in inflammatory immune gene activity in the infected cells.

The teams most surprising finding, however, was that the pacemaker cells, in response to the stress of infection, showed clear signs of a cellular self-destruct process called ferroptosis, which involves accumulation of iron and the runaway production of cell-destroying reactive oxygen molecules. The scientists were able to reverse these signs in the cells using compounds that are known to bind iron and inhibit ferroptosis.

This finding suggests that some of the cardiac arrhythmias detected in COVID-19 patients could be caused by ferroptosis damage to the sinoatrial node, said co-senior author Dr. Robert Schwartz, an associate professor of medicine in the Division of Gastroenterology and Hepatology at Weill Cornell Medicine and a hepatologist at NewYork-Presbyterian/Weill Cornell Medical Center.

Although in principle COVID-19 patients could be treated with ferroptosis inhibitors specifically to protect sinoatrial node cells, antiviral drugs that block the effects of SARS-CoV-2 infection in all cell types would be preferable, the researchers said.

The researchers plan to continue to use their cell and animal models to investigate sinoatrial node damage in COVID-19and beyond.

There are other human sinoatrial arrhythmia syndromes we could model with our platform, said co-senior author Dr. Todd Evans, the Peter I. Pressman M.D. Professor of Surgery and associate dean for research at Weill Cornell Medicine. And, although physicians currently can use an artificial electronic pacemaker to replace the function of a damaged sinoatrial node, theres the potential here to use sinoatrial cells such as weve developed as an alternative, cell-based pacemaker therapy.

Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosurespublic to ensure transparency. For this information, see profiles for Dr. Todd Evans, and Dr. Robert Schwartz.

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Are COVID-19-Linked Arrhythmias Caused by Viral Damage to the Heart's Pacemaker Cells? - Weill Cornell Medicine Newsroom

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Evidence Rating Level:1 (Excellent)

Study Rundown:Duchenne muscular dystrophy (DMD) is an X-linked genetic disorder characterized by progressive muscle degeneration leading to significant reduction in life expectancy. Males with DMD have an estimated life expectancy of 22 years with heart and respiratory muscles affected in later disease stages. In this phase 2 trial, a formulation of allogenic cardiosphere-derived cells (CAP-1002) was evaluated against placebo in patients with DMD. CAP-1002 is, in essence, a concentrate of cardiac stem cells with potential disease-modifying properties such as regenerative abilities. Participants (n=20) were randomized 1:1 to receive either CAP-1002 or placebo every three months for four total infusions. Primary outcome was upper limb function measured by a scale of 0-6 (PUL). CAP-1002 was shown to slow PUL decline by 71% compared to placebo or by an absolute difference of 2.6 points. CAP-1002 was generally well-tolerated with only one severe adverse hypersensitivity reaction leading to withdrawal from the trial. Limitations of this study include the small sample size. Nonetheless, this study provides promising preliminary results for a potential disease-modifying therapy in DMD.

Click to read the study in the Lancet

Relevant Reading:Long-term effects of glucocorticoids on function, quality of life, and survival in patients with Duchenne muscular dystrophy: a prospective cohort study.

In-Depth [randomized controlled trial]:HOPE-2 was a randomized-controlled phase 2 clinical trial to assess to safety and efficacy of intravenous CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). The study enrolled patients aged 10 and older with genetically confirmed DMD. Participants had to score between 2-5 on the Performance of Upper Limb (PUL) scale with 0 being no useful function of hands and 6 being maximum overhead reach without compensation. 20 participants were assigned 1:1 to either CAP-1002 (n=8) or placebo (n=12) infusion every 3 months for a total of four infusions. Mean age of the enrolled male participants was 14 in both groups. Primary outcome was the upper limb function on the PUL scale. Patients who received CAP-1002 had a greater change in PUL score from baseline after 12 months compared to placebo (percentile difference 36.2, 95% CI 12.7-59.7). On the PUL scale, the placebo group had a mean change of -3.4 points from baseline, while the CAP-1002 had a -0.8 point change (difference of 2.6 points). This can also be interpreted as a 71% slowing of loss of function in the CAP-1002 group. Three patients in the CAP-1002 group had infusion-related hypersensitivity reactions, one leading to discontinuation. No other adverse events were seen in the two groups.

2022 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

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#VisualAbstract: Cardiosphere-derived cell therapy slows disease progression in Duchenne muscular dystrophy - Physician's Weekly

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-- Yescarta is First CAR T-cell Therapy to Receive NCCN Treatment Guideline Category 1 Recommendation --

Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220401005519/en/

Earlier this month, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for B-cell Lymphomas to include Yescarta for "Relapsed disease

Christi Shaw, Chief Executive Officer of Kite : "Kite started with a very bold goal: creating the hope of survival through cell therapy. Today's FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy."

CAR T-cell therapies are individually made starting from a patient's own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite's specialized manufacturing facilities where they are engineered to target the patient's cancer, expanded, and then returned to the hospital for infusion back into the patient. Referring physicians and patients can immediately begin accessing Yescarta CAR T-cell therapy for this new FDA-approved indication through Kite's 112 authorized treatment centers across the U.S.

Frederick L. Locke, MD, ZUMA-7 Principal Investigator and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida : "Today's approval marks an exciting new standard of care. The ZUMA-7 trial enabled us to look at the broader picture of what happens to patients after a decision is made to follow a particular treatment path. What we found was that axi-cel resulted in three times as many patients receiving treatment with curative intent (CAR T-cell therapy), and an overall better outcome for patients than the previous standard of care. Additionally, we have now amassed significant experience with CAR T-cell therapy to better manage or prevent side-effects, making this treatment more accessible for older patients and those with medical conditions for whom the standard of care might be difficult."

SOC therapy for this patient population has historically been a multi-step process expected to end with a stem cell transplant. The process starts with chemoimmunotherapy, and if a patient responds to and can tolerate further treatment, they move on to high-dose chemotherapy (HDT) followed by a stem cell transplant (ASCT).

Jason Westin, MD, MS, FACP, ZUMA-7 Principal Investigator, Director, Lymphoma Clinical Research, and Associate Professor, Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center : "Definitive clinical trial results such as these do not come along often and should drive a paradigm shift in how patients with relapsed or refractory LBCL are treated moving forward. Patients who do not respond to or relapse after initial treatment should quickly be referred to a CAR T-cell therapy authorized treatment center for evaluation."

Kite CAR T-cell therapy products are widely covered by commercial and government insurance programs in the U.S. Kite has also invested in expansion of manufacturing capacity ahead of today's FDA decision to support patient access.

Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS): "LLS was an early supporter of CAR T-cell therapy research, and to be able to see this innovative advance become available as an earlier line of treatment is truly remarkable. Current standard of care is a difficult process for patients, and no one knows at the start who will make it to stem cell transplant. With today's FDA decision, patients will have earlier access to this potentially curative treatment."

Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy. The ZUMA-1 trial has recently reported durable 5-year survival results, with Yescarta showing 42.6% of study patients alive at 5 years and that 92% of those patients alive at 5 years have needed no additional cancer treatment at this important milestone.

As the only company dedicated exclusively to the research, development, commercialization, and manufacturing of cell therapy on a global scale, Kite has all functions critical to cell therapy vertically integrated. This structure enables the continual refinement and support of the highly specialized and complex end-to-end processes needed to support and improve upon patient outcomes with CAR T-cell therapy.

About ZUMA-7 Study

The FDA approval of Yescarta CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy is based on results from the ZUMA-7 study. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous stem cell transplant (ASCT). Results were presented in a Plenary session at the American Society of Hematology's (ASH) Annual Meeting & Exposition in December 2021 and simultaneously published in the New England Journal of Medicine (NEJM).

ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of Yescarta versus current standard of care (SOC) for second-line therapy (platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy [HDT] and ASCT in those who respond to salvage chemotherapy) in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. In the study, 359 patients in 77 centers around the world were randomized (1:1) to receive a single infusion of Yescarta or current SOC second-line therapy. The primary endpoint is event-free survival (EFS) as determined by blinded central review and defined as the time from randomization to the earliest date of disease progression per Lugano Classification, commencement of new lymphoma therapy, or death from any cause. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Additional secondary endpoints include patient reported outcomes (PROs) and safety.

Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment (40.5% vs. 16.3%) and a four-fold greater median EFS (8.3 mo. vs. 2.0 mo.) compared to SOC (hazard ratio 0.398; 95% CI: 0.308-0.514, P

Nearly three times as many patients randomized to Yescarta ultimately received the definitive CAR T-cell therapy treatment (94%) versus those randomized to SOC (35%) who received on-protocol HDT+ASCT. More patients responded to Yescarta (ORR: 83% vs. 50%, odds ratio: 5.31 [95% CI: 3.1-8.9; P

Fifty-five percent of patients in the SOC arm subsequently received CD19-directed CAR T-cell therapy off study.

In the study, Yescarta had a safety profile that was consistent with previous studies. Among the 168 Yescarta-treated patients evaluable for safety, Grade 3 cytokine release syndrome (CRS) and neurologic events were observed in 7% and 25% of patients, respectively. In the SOC arm, 83% of patients had high grade events, mostly cytopenias (low blood counts).

The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

About LBCL

Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment.

About Yescarta

Please see full Prescribing Information , including BOXED WARNING and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Limitations of Use : YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS ( 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities ( 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at http://www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 infections occurred in 17% of patients, including Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS

The most common non-laboratory adverse reactions (incidence 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

The most common non-laboratory adverse reactions (incidence 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com .

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing or additional clinical trials involving Yescarta; Kite's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving Yescarta; Kite's ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of Yescarta, and the risk that any such approvals may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing Yescarta; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta including BOXED WARNING , is available at http://www.kitepharma.com and http://www.gilead.com .

Kite, the Kite logo, Yescarta, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company's website at http://www.kitepharma.com . Follow Kite on social media on Twitter ( @KitePharma ) and LinkedIn .

View source version on businesswire.com: https://www.businesswire.com/news/home/20220401005519/en/

Jacquie Ross, Investors investor_relations@gilead.com

Mary Lynn Carver, Media mcarver@kitepharma.com

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Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial -...

Cardiac Stem Cells Comments Off on Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial -… | April 3rd, 2022