Course Description: Regenerative medicine focuses on harnessing the power of ones own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administrations (FDA) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

This 2-day interactive seminar on FDA regulations of regenerative medicine will cover:

-How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use. -The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products. -The New Drug Application (NDA) and the Biologic License Application (BLA) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements. -The option for obtaining designation and approval as Orphan Drug Product. -Designing and conducting appropriate clinical trials to support the approval of regenerative therapies. -FDAs regulation of some regenerative medicine products and accessories as Medical Devices. -The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products. -The labeling and marketing of regenerative products and therapies. -The potential for enforcement action and recommendations for mitigating that risk. -The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States.

Learning Objectives: Participants who attend this course on FDA regulation of regenerative medicines will leave with a comprehensive understanding of:

-How FDA regulates regenerative treatments and therapies? -The HCT/P Criteria and Minimal Manipulation Standard. -The Drug and Biological Approval Process. -Regenerative Products as Medical Devices. -How to Design Appropriate Clinical Trials? -Applicable cGMPs and cGLPs. -Marketing Exclusivity and Patent Restoration. -Product Labeling, Marketing and Advertising. -FDA and other Federal Agency Enforcement Action. -The Regulation of Veterinary Regenerative Medicine. -The New Animal Drug Application (NADA) Process. -Veterinary User Fees and Waivers.

Who will benefit: This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

-Senior quality managers -Quality professionals -Regulatory professionals -Compliance professionals -Production supervisors -Manufacturing engineers -Production engineers -Design engineers -Labelers and Private Labelers -Contract Manufacturers -Importers and Custom Agents -U.S. Agents of Foreign Corporations -Process owners -Quality engineers -Quality auditors -Document control specialists -Record retention specialists -Medical affairs -Legal Professionals -Financial Advisors and Institutional Investors -Consultants, Inspectors and cGMP Experts

Link:
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering, Etc.

Philadelphia, PA (PRWEB) March 13, 2014

Bioquark, Inc., (http://www.bioquark.com) a company focused on the development of combinatorial biologics for regeneration and disease reversion in human organs and tissues, today announces the appointment of Dr. Luis Martinez, MD, MPH, as VP of Global Operations.

We are honored to have someone with Dr. Martinezs experience join us as we execute on a globalized strategy in regenerative medicine, said Ira S. Pastor, CEO, Bioquark Inc. His broad clinical experience in applied regenerative medicine and cellular therapies make him a very valuable addition to the Bioquark team.

Dr. Martinez is a regenerative medicine and cell therapy specialist with over 10 years of experience in the clinical setting. He is currently the President of Elite Regenerative Medicine Group, a premier treatment and research center specializing in cell therapy applications for therapeutic, regenerative and preventive purposes. Dr. Martinez obtained his medical degree, as well as his Master of Public Health, at the Ponce School of Medicine and Health Sciences, and completed his residency at the prestigious University of Pennsylvania. He also completed a fellowship in biosecurity with the UPMC Center for Health Security. He is currently a clinical instructor at the Ponce School of Medicine and Health Sciences and is a board certified physician. Dr. Martinez also serves as vice-president of the XanoGene Anti-Aging Clinic and is President at Xyrion Medical, a biomedical consulting firm. He is a current consultant for multiple biomedical and pharmaceutical companies and conducts clinical research for various clients in the industry. Dr. Martinez is also a renowned international speaker, speaking at multiple venues for professional and academic organizations and he offers training to physicians in multiple applications of regenerative medicine, including Platelet Rich Plasma (PRP) therapy, adipose and bone marrow stem cell derived harvesting, preparation and therapeutic administration, as well as cytokine, growth factor and peptide therapies.

I am very excited about the biologic candidates being developed at Bioquark Inc. and their very novel approach to human regeneration and disease reversion, which has broad clinical applicability towards a range of degenerative disorders," said Dr. Martinez. "I'm pleased to be joining the team and am looking forward to playing a more active role in this truly transformational platform."

About Bioquark, Inc.

Bioquark Inc. is focused on the development of biologic based products that have the ability to alter the regulatory state of human tissues and organs, with the goal of curing a wide range of diseases, as well as effecting complex regeneration. Bioquark is developing biological pharmaceutical candidates, as well as products for the global consumer health and wellness market segments.

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Bioquark Inc. Announces the Appointment of Dr. Luis Martinez, MD, MPH, Regenerative Medicine and Cell Therapy ...

Watch the video above:Leukemia patient Chris Taylor loses 2nd bone marrow transplant donor. Angie Seth reports.

TORONTO A 36-year-old leukemia patient is searching for a bone marrow donor for the third time, after his first two donors backed out for medical or unknown reasons.

Chris Taylor was diagnosed with leukemia in 2012. He originally went to Mount Sinai hospital with chest pains and spent several days in the ICU though doctors couldnt figure out what was wrong with him, he said.

But several weeks later, Princess Margaret Hospital found his cancer at the chromosomal level. HE immediately started chemotherapy and it went into remission.

It came back after ten months, he said. I was starting to feel better and the side effects were starting to wear off and then the cancer came back.

They found a match around Christmas of 2013, he said. They started preliminary testing and even got a proposed date but two days before, the donor pulled out.

Unfortunately that donor was medically unfit to donate, Taylor said.

So they went back to searching. They found another donor.

We began again the process of getting ready to go in for the transplant, he said. Unfortunately for unknown reasons that donor had to opt-out of the procedure.

I was disappointed but I dont hold any ill-will or anything like that.

Originally posted here:
Man hoping for third stem cell match after first 2 donors back out

Richard France has been visiting Pine Island for 18 years. Each winter he escapes the Ohio winters for the sunny warmth of Pine Island for about six months a year.

"In 2008 I was diagnosed when I was 68 years old with acute leukemia," France said. "I underwent treatments for a fair amount of time, 4 or 5 months - chemotherapy. We usually come down in January but that year we were here for March and April."

He continued, "After that I was in remission for three years but then in 2011 we were here in Florida and I got a call from my doctor. He said the cancer had returned and that I needed to get back to Ohio. They recommended that I have a bone marrow transplant and I got on the transplant list. I think it was under a year when I got word that they had a donor. By then they had decided against a bone marrow transplant and were looking for a stem cell donor. It was the day before Thanksgiving that I went into the hospital and I stayed until almost Christmas. On Nov. 30, I got Laurie Burnworth's stem cells."

Laurie Burnworth stem cell donor and Richard France recipient.

PHOTO PROVIDED

A stem cell (blood or marrow) transplant is the infusion, or injection, of healthy stem cells into your body to replace damaged or diseased stem cells. A stem cell transplant may be necessary if your bone marrow stops working and doesn't produce enough healthy stem cells. A stem cell transplant also may be performed if high-dose chemotherapy or radiation therapy is given in the treatment of blood disorders such as leukemia, lymphoma or multiple myeloma.

"I've been donating blood for years," Burnworth said. "I think I may have signed up for this at one of those times I signed up for blood but I really don't remember. It seems one thing led to another and I believe we were matched up in 2008 and they called me. But that's when Richard went into remission and they held off. Then in 2011 they contacted me again and said 'You are the perfect match for this gentleman and if you're still interested we're going to do this.' After extensive testing we went ahead.

"I think a lot of people don't sign up because they think they take the material from the bone," Burnworth continued. "But in my case you just go to the blood bank, which for me was in Rockford, Ill., and sit in a chair and then you just get hooked up like you're donating blood the difference being though is you're hooked up with both arms. One arm collects the blood where it is sent to a centrifuge that separates the platelets and then the blood is returned through the other arm to your body.

"It's really not a bad process," Burnworth said. "It takes a little time but this is the result. For the first year you can correspond with each other anonymously. Then after a year you sign forms releasing the information. It was Christmas 2012 that I got my phone call from Richard. And, of course, I didn't recognize the phone number so I didn't answer but he left a message and I immediately called back. That's when it really hit me and I cried because Richard and his family got to celebrate Christmas. Then this year they got to celebrate their 50th wedding anniversary and I cried again."

"We meant to get together last year but didn't," France said. "My wife urged that we get together this year and here we are. It's been two years since I got my transplant and I've got another three to go before I'm considered cured. I'm getting pretty much everything back and I feel wonderful and I'm so thankful for Laurie. I wish more people would look into donating organs in general."

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Stem cell donor, recipient get together

PUBLIC RELEASE DATE:

12-Mar-2014

Contact: Camille Gamboa camille.gamboa@sagepub.com 805-410-7441 SAGE Publications

Los Angeles, CA (March 12, 2014) Researchers have found that sutures embedded with stem cells led to quicker and stronger healing of Achilles tendon tears than traditional sutures, according to a new study published in the March 2014 issue of Foot & Ankle International (published by SAGE).

Achilles tendon injuries are common for professional, collegiate and recreational athletes. These injuries are often treated surgically to reattach or repair the tendon if it has been torn. Patients have to keep their legs immobilized for a while after surgery before beginning their rehabilitation. Athletes may return to their activities sooner, but risk rerupturing the tendon if it has not healed completely.

Drs. Lew Schon, Samuel Adams, and Elizabeth Allen and Researchers Margaret Thorpe, Brent Parks, and Gary Aghazarian from MedStar Union Memorial Hospital in Baltimore, Maryland, conducted the study. They compared traditional surgery, surgery with stem cells injected in the injury area, and surgery with special sutures embedded with stem cells in rats. The results showed that the group receiving the stem cell sutures healed better.

"The exciting news from this early work is that the stem cells stayed in the tendon, promoting healing right away, during a time when patients are not able to begin aggressive rehabilitation. When people can't fully use their leg, the risk is that atrophy sets in and adhesions can develop which can impact how strong and functional the muscle and tendon are after it is reattached," said Dr. Schon. "Not only did the stem cells encourage better healing at the cellular level, the tendon strength itself was also stronger four weeks following surgery than in the other groups in our study," he added.

###

For further information on how to take care of your feet and ankles, or to find a local orthopaedic foot and ankle surgeon, visit the American Orthopaedic Foot & Ankle Society patient website at http://www.footcaremd.org.

"Stem Cell-Bearing Suture Improves Achilles Tendon Healing in a Rat Model" by Samuel B. Adams, Jr, MD; Margaret A. Thorpe, BS; Brent G. Parks, MSc; Gary Aghazarian, BS; Elizabeth Allen, MD; and Lew C. Schon, MD in the March 2014 Foot & Ankle International.

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Stem cells inside sutures could improve healing in Achilles tendon injuries

Sarasota, FL (PRWEB) March 12, 2014

Erectile dysfunction (ED) is the most commonly studied disorder when it comes to male sexual dysfunction. It is estimated that 18 million men in the US alone suffer from erectile dysfunction and that it appears to be affecting 1 in 4 males under age 40 according to a study published in The Journal of Sexual Medicine.

While the emphasis of treatments for ED focuses on relieving the symptoms, they only provide a temporary solution rather than a cure or reversing the cause.

The DaSilva Institute is excited to announce the recruitment of males suffering from ED, in an IRB study, which will look at the safety, and efficacy of autologous, adipose derived stem cells (ADSCs) in regenerating the causes of ED.

The evidence shows that ADSCs reverses the pathophysiological changes leading to ED, rather than treating the symptoms of ED. Not only is the data in the literature compelling, but our own, in-house, results on our patients have been phenomenal, states Dr. DaSilva.

The many underlying causes for ED that are being investigated range from those secondary to aging, to injury of the cavernous nerve secondary to injury, surgery and/or radiation of the prostate, to diabetic ED and Peyronies Disease to name a few. According to Dr. DaSilva, the possibilities for ADSCs in reversing ED are limitless.

Currently, there is an expansive and growing body of evidence in the medical literature strongly indicating that ADSCs might be a potential cure for ED, rather than merely symptom relief, which is indicative of the increasing interest in ADSC-regenerative options for sexual medicine over the past decade. The DaSilva Institutes goal is to take this from pre-clinical studies to the clinical world offering it to all males that suffer from intractable ED under an IRB approved protocol.

More information about Dr. DaSilva and the DaSilva Institute Guy DaSilva, MD is currently the medical director of the DaSilva Institute of Anti-Aging, Regenerative & Functional Medicine, located in Sarasota, Florida. Dr. DaSilvas enthusiasm for using autologous stem cells in regenerative medicine comes from his early days as a pathologist in New York City back in 1987 and later as a fellow in hematology in1990 following his residency in internal medicine.

He later brought his expertise in molecular and cellular medicine to the University of Kansas Medical Center where he served as chief of Hematology & Hematopathology. He later became the CEO and medical director of HemePath Institute, a diagnostic leader in diagnosing the most difficult cases of leukemia and lymphomas. Most recently, Dr. DaSilva teamed up with one of the most influential stem cell scientist in the world to bring the highest quality and viability of the harvested stem cells, bar none, to the DaSilva Institute.

Dr. DaSilva is board certified and fellowship trained in Anti-Aging and Regenerative Medicine. For more information about Dr. DaSilva or the DaSilva Institute go to http://www.dasilvainstitute.com.

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DaSilva Institute of Anti-Aging, Regenerative & Functional Medicine Offers Autologous Stem Cell Therapy for Men ...

Boca Raton, Florida (PRWEB) March 12, 2014

The Miami Stem Cell Treatment Center, PC, located in Miami, Ft. Lauderdale, and Boca Raton, Florida, offers a free public seminar on the use of stem cells for various degenerative and inflammatory conditions. They will be provided by Dr. Thomas A. Gionis, Surgeon-in-Chief, and, Dr. Nia Smyrniotis, Medical Director. The next upcoming seminar will be held on March 16th at the Comfort Suites Weston, 2201 N. Commerce Parkway, Weston, Florida 33326, at 2pm.

Regenerative Medicine: Our Procedure The Miami Stem Cell Treatment Center uses Autologous Adult Adipose Stem Cells to provide care for patients suffering from chronic conditions that may benefit from adult stem cell-based regenerative medicine.

The Miami Stem Cell Treatment Center follows the regenerative medicine procedures developed by the California Stem Cell Treatment Centers (CSCTC) and Cell Surgical Network (CSN) which involves the initial screening, examination and evaluation of every potential candidate for stem cell investigational therapy by one of our physicians. Once a patient is deemed to be an appropriate candidate, the procedure itself is performed by our Surgeon-in-Chief, who is assisted by a team of experienced surgical team members and surgical technicians. The entire process from start to finish takes less than two hours. It is relatively painless, and recovery time is minimal.

In recent times, the bone marrow has been a source for stem cells. Taking bone marrow, however, is a painful procedure. Fat, however, contains many times more stem cells than bone marrow and is much easier and safer to harvest.

For many disease types such as cardiac pathology, adipose derived cells appear to be showing superiority to bone marrow derived cells. This may be related to the well documented fact that chronic disease causes bone marrow suppression. Fat derived cells are a natural choice for our investigational work considering their easy and rapid availability in extremely high numbers.

With our current technology, we can harvest your own fat cells, digest the fat cells and separate out the stem cells. The most significant advantage of using your fat as a source for the stem cells, is that the procedure can be done in the office in only a few hours, as the stem cells can be ready for injection after only 60 minutes of processing with our state of the art equipment. Your stem cells do NOT need to be sent out for processing and there is no need for you to travel outside of the U.S. to have them injected.

Indeed, adipose tissue is an abundant source of mesenchymal stem cells, which have shown promise in the field of regenerative medicine. Furthermore, these cells can be readily harvested in large numbers with low donor-site morbidity. During the past decade, numerous studies have provided pre-clinical data on the safety and efficacy of adipose-derived stem cells, supporting the use of these cells in clinical applications. Various clinical trials have shown the regenerative capability of adipose-derived stem cells in numerous fields of medicine. In addition, a great deal of knowledge concerning the harvesting, characterization, and culture of adipose-derived stem cells has been reported.

Our current areas of study include: Heart Failure, Emphysema, COPD, Asthma, Parkinsons Disease, Stroke, Multiple Sclerosis, and orthopedic joint injections. . The investigational protocols utilized by the Miami Stem Cell Treatment Center have been reviewed and approved by an IRB (Institutional Review Board) which is registered with the U.S. Department of Research Protections; and the study is registered with http://www.Clinicaltrials.gov, a service of the U.S. National Institutes of Health (NIH). For more information contact: Miami(at)MiamiStemCellsUSA(dot)com or visit our website: http://www.MiamiStemCellsUSA.com.

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Miami Stem Cell Treatment Center: What The Stem Cell Procedure Entails and An Invitation To MSCTC Public Seminar; Meet ...

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Newswise COLUMBUS, Ohio -- Imagine a world where malfunctioning organs are replaced by new ones made from your own tissues, where infected wounds are cured with a signal from your smartphone, where doctors find the perfect medicine for whatever ails you simply by studying your stem cells.

Its a world thats inching closer to reality because of the work of some of the nations top scientists, many of whom will gather March 13-15 at The Ohio State University for the 7th Annual Translational to Clinical (T2C) Regenerative Medicine Conference to discuss their recent successes and challenges in coaxing the body to heal itself in extraordinary ways.

Regenerative medicine will change the way you and I experience sickness, health and healthcare, said Chandan Sen, director of the Center for Regenerative Medicine and Cell Based Therapies at Ohio States Wexner Medical Center. Because the field is so new, we as researchers are also changing the way we work to be synergistic not competitive, so patients are able to access the benefits more quickly.

And the benefits are desperately needed, says keynote speaker Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine at Wake Forest Baptist Medical Center.

From chronic diseases such as kidney failure that costs billions of dollars each year to the medical needs of our aging population and the significant injuries sustained by military troops in Afghanistan, developing new treatment paradigms is essential, said Atala, who was selected to lead the $75 million Armed Forces Institute of Regenerative Medicine (AFIRM), a consortium of 30 academic and industry partners in applying regenerative medicine techniques to battlefield injuries.

In theory, every tissue in the body has the ability to regenerate and heal itself. Its good to come to this meeting and exchange ideas that will enable us to harness that remarkable ability.

Other speakers include Elaine Fuchs, Howard Hughes Medical Institute investigator and Rebecca C. Lancefield Professor at Rockefeller University in New York, who has advanced multiple areas of stem cell research through her work in skin cells and genetics; and Dr. Michael Longaker, director of the Hagey Laboratory for Stem Cell Biology for Pediatric Regenerative Medicine at Stanford University. Longaker is considered one of the nations experts in using a combination of stem cell- and bioengineering-based technologies for craniofacial reconstruction.

Several Ohio State College of Medicine and Wexner Medical Center clinician-scientists are also sharing research updates during pre-conference lectures and the meeting:

Excerpt from:
Advances in Stem Cell, Organ Printing, Tissue Engineering Changing Healthcare, Saving Lives

The parents of a 2-year-old Pasadena girl who was diagnosed with an aggressive form of leukemia were this week renewing calls for help in their search for a bone marrow donor after stem cells donated from the girls father failed to help.

Sofia Flores, shown in a family photo, needs a bone marrow donor.

Sofia Flores story first came to light in October 2013 when her parents asked for help in finding a bone marrow donor for their daughter.

Sofia needed a marrow transplant to combat acute myeloid leukemia, according to A3M, a Los Angeles nonprofit that is helping Sofias parents seek a match for the little girl.

However, after an extensive search, no match was found.

On Jan. 23, her father donated his stem cells to her, which was the only alternative available at the time, according to Erica Westfall, Sofias mother.

But the treatment was not successful and Sofias cancer relapsed.

Sofias last chance for survival would be a transplant from an unrelated donor in the next two months, according to her mother.

Weve been searching for a bone marrow match even harder because this is her last chance, her father Ignacio Flores said in a video released to news media on Monday.

Sofia has not found a donor through the Be the Match registry, in part because her mixed-race ethnicity makes it difficult to find a compatible donor, according to A3M. Sofia is half white and half Mexican.

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Father of 2-Year-Old in Need of Bone Marrow: This Is Her Last Chance

PUBLIC RELEASE DATE:

11-Mar-2014

Contact: Karen Richardson krchrdsn@wakehealth.edu 336-716-4453 Wake Forest Baptist Medical Center

WINSTON-SALEM, N.C. March 11, 2014 Discovering where a common virus hides in the body has been a long-term quest for scientists. Up to 80 percent of adults harbor the human cytomegalovirus (HCMV), which can cause severe illness and death in people with weakened immune systems.

Now, researchers at Wake Forest Baptist Medical Center's Institute for Regenerative Medicine report that stem cells that encircle blood vessels can be a hiding place, suggesting a potential treatment target.

In the American Journal of Transplantation (online ahead of print), senior scientist Graca Almeida-Porada, M.D., Ph.D., professor of regenerative medicine at Wake Forest Baptist, and colleagues report that perivascular stem cells, which are found in bone marrow and surround blood vessels in the body's organs, are a reservoir of HCMV.

The virus, which is part of the herpes family, is unnoticed in healthy people. Half to 80 percent of all adults in the U.S. are infected with HCMV, according to the Centers for Disease Control and Prevention. In people with weakened immune systems, including those with HIV, undergoing chemotherapy, or who are organ or bone marrow transplant recipients, the virus can become re-activated.

Once re-activated, HCMV can cause a host of problems from pneumonia to inflammation of the liver and brain that are associated with organ rejection and death.

"There are anti-viral medications designed to prevent HCMV from re-activating, but HVMC infection remains one of the major complications after both organ and bone marrow transplants," said Almeida-Porada. "The question scientists have been asking for years is, 'Where does the virus hide when it is latent?' Maybe if we knew, we could target it."

Scientists have previously shown that one hiding place is hematopoietic stem cells, which give rise to blood cells. "There has been research on and off looking for the other hiding places," said Almeida-Porada. "Identifying the cells that can harbor the virus and are responsible for its re-activation could potentially lead to development of novel targeted therapies."

Originally posted here:
Finding hiding place of virus could lead to new treatments

Auckland scientists have discovered new cells with stem cell properties in human skin, opening the door to a range of new treatments for skin diseases and unhealed wounds.

Auckland scientists have discovered new cells with stem cell properties in human skin, opening the door to a range of new treatments for skin diseases and unhealed wounds.

The scientists, Professor Rod Dunbar, Dr Vaughan Feisst, Dr Anna Brooks and Jenni Chen, are members of the Maurice Wilkins Centre for Molecular Biodiscovery, and the research was carried out in the School of Biological Sciences at the University of Auckland.

They identified mesenchymal progenitor cells (MPCs) in the dermis, the middle layer of skin, and discovered that these could turn themselves into fat cells. This signals that they can probably become other types of cells that repair and regenerate tissue, like similar stem cells found in fat and bone marrow.

"Nobody has identified these cells before, so this opens the door to advances in both skin healing and skin diseases," says Professor Dunbar. "Every time you find new cells with stem cell-like properties, you know youre onto something that could have major implications."

"Its a really exciting discovery," he adds. "We try to avoid getting too carried away about our results because were constitutionally cautious - but this discovery is a pretty fundamental finding."

The team hopes that its research, which started in 2011, could eventually lead to treatments for conditions that severely thicken the skin such as keloid scarring, in which tough, irregularly-shaped scars grow and spread. The team also suspects loss of these MPC cells may prevent proper healing, when, for example, radiation treatment for cancer has damaged the skin.

The tissue used in the research came from men and women who had undergone procedures such as liposuction, abdominoplasty or breast reduction with Auckland surgeons Ms Michelle Locke, Mr Jonathan Wheeler and Mr Julian Lofts. All patients consented to their tissue being used for the study.

The research involved sorting many millions of cells - "like sorting mixed-up flocks of sheep into their different breeds", says Professor Dunbar - with a laser-based technology called flow cytometry.

The research is published this week as the cover article in the March 2014 edition of the international journal Stem Cells and Development.

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Auckland scientists discover new stem cell in human skin

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Newswise SAN DIEGO Elaine Fuchs, Ph.D., will receive the 2014 Pezcoller Foundation-American Association for Cancer Research (AACR) International Award for Cancer Research at the AACR Annual Meeting 2014, to be held in San Diego, Calif., April 5-9, in recognition of her seminal work contributing to the understanding of mammalian skin, skin stem cells, and skin-related diseases, particularly cancers, genetic diseases, and proinflammatory disorders.

Fuchs is the Rebecca C. Lancefield professor and head of the Laboratory of Mammalian Cell Biology and Development at The Rockefeller University in New York, N.Y., and an investigator of the Howard Hughes Medical Institute. She will give her lecture, Stem Cells in Silence, Action, and Cancer, Sunday, April 6, 4:30 p.m. PT, in Halls F-G in the San Diego Convention Center.

Dr. Fuchs is an exceptional scientist, and we are delighted to recognize her pioneering research on the biology of skin stem cells and how they go awry in human diseases of the skin, including cancer, said Margaret Foti, Ph.D., M.D. (hon.), chief executive officer of the AACR. Her seminal studies have had a profound impact not only on the field of cancer research, but also on the research disciplines of genetics and dermatology.

Fuchs is highly regarded for her studies using reverse genetics to understand the biological basis of normal and abnormal skin development and function. Among her important research discoveries was the clarification of the molecular mechanisms underlying the ability of skin stem cells to produce the epidermis and its appendages, including hair follicles and sweat and oil glands. She has also defined how the normal biology of skin stem cells can be deregulated in skin cancers and other hyperproliferative disorders of the skin.

I'm honored, delighted, and humbled to receive this award from the AACR, said Fuchs. My students, postdocs, and staff, present and past, are the ones who truly merit recognition. My group has long had an interest in skin stem cells, how they make and repair tissues, and how this goes awry in cancers. As a basic scientist who studies the fundamental mechanisms underlying stem cell biology and cancer, it is particular pleasing to be recognized not only by basic cancer biologists, but also by physician scientists and clinicians. It is the diversity and breadth of the AACR that make this Society and this honor so special.

The Pezcoller Foundation-AACR International Award, now in its 17th year, recognizes an individual scientist of international renown who has made a major scientific discovery in basic or translational cancer research.

As recipient of this award, Fuchs will also present the Ninth Annual Stanley J. Korsmeyer Lecture at the Venetian Institute for Molecular Medicine in Padua, Italy, prior to the Pezcoller Foundations official award ceremony in Trento, Italy, May 2014.

Fuchs was named one of the inaugural Fellows of the AACR Academy last year. She has received many additional honors throughout her career, including the AACR-Women in Cancer Research Charlotte Friend Memorial Lectureship, the National Medal of Science, the Albany Prize in Medicine, the Kligman-Frost Leadership Award from the Society of Investigative Dermatology, LOreal-Unesco Award, the March of Dimes Prize, and the Pasarow Award for Cancer Research. She is an elected member of the National Academy of Sciences, the Institute of Medicine, the American Philosophical Society, the American Academy of Arts and Sciences, and the European National Academy of Sciences (EMBO).

The rest is here:
Pezcoller Foundation and American Association for Cancer Research Honor Outstanding Achievements of Dr. Elaine Fuchs

PUBLIC RELEASE DATE:

11-Mar-2014

Contact: Lauren Riley lauren.riley@aacr.org 215-446-7155 American Association for Cancer Research

SAN DIEGO Elaine Fuchs, Ph.D., will receive the 2014 Pezcoller Foundation-American Association for Cancer Research (AACR) International Award for Cancer Research at the AACR Annual Meeting 2014, to be held in San Diego, Calif., April 5-9, in recognition of her seminal work contributing to the understanding of mammalian skin, skin stem cells, and skin-related diseases, particularly cancers, genetic diseases, and proinflammatory disorders.

Fuchs is the Rebecca C. Lancefield professor and head of the Laboratory of Mammalian Cell Biology and Development at The Rockefeller University in New York, N.Y., and an investigator of the Howard Hughes Medical Institute. She will give her lecture, "Stem Cells in Silence, Action, and Cancer," Sunday, April 6, 4:30 p.m. PT, in Halls F-G in the San Diego Convention Center.

"Dr. Fuchs is an exceptional scientist, and we are delighted to recognize her pioneering research on the biology of skin stem cells and how they go awry in human diseases of the skin, including cancer," said Margaret Foti, Ph.D., M.D. (hon.), chief executive officer of the AACR. "Her seminal studies have had a profound impact not only on the field of cancer research, but also on the research disciplines of genetics and dermatology."

Fuchs is highly regarded for her studies using reverse genetics to understand the biological basis of normal and abnormal skin development and function. Among her important research discoveries was the clarification of the molecular mechanisms underlying the ability of skin stem cells to produce the epidermis and its appendages, including hair follicles and sweat and oil glands. She has also defined how the normal biology of skin stem cells can be deregulated in skin cancers and other hyperproliferative disorders of the skin.

"I'm honored, delighted, and humbled to receive this award from the AACR," said Fuchs. "My students, postdocs, and staff, present and past, are the ones who truly merit recognition. My group has long had an interest in skin stem cells, how they make and repair tissues, and how this goes awry in cancers. As a basic scientist who studies the fundamental mechanisms underlying stem cell biology and cancer, it is particular pleasing to be recognized not only by basic cancer biologists, but also by physician scientists and clinicians. It is the diversity and breadth of the AACR that make this Society and this honor so special."

The Pezcoller Foundation-AACR International Award, now in its 17th year, recognizes an individual scientist of international renown who has made a major scientific discovery in basic or translational cancer research.

As recipient of this award, Fuchs will also present the Ninth Annual Stanley J. Korsmeyer Lecture at the Venetian Institute for Molecular Medicine in Padua, Italy, prior to the Pezcoller Foundation's official award ceremony in Trento, Italy, May 2014.

See the article here:
Pezcoller Foundation and AACR honor outstanding achievements of Dr. Elaine Fuchs

Health

Teruhiko Wakayama, a respected stem cell scientist from Japans RIKEN Institute, said he is not certain about the methods used in two studies he co-authored with lead investigator Haruko Obokata.

In the ground-breaking work, heralded by some in the field as a game-changer in the way stem cells are made, Obokata and her team, which included researchers from Harvard University and other international institutes, detailed how they were able to coax already developed cells to revert back to an embryonic-like state to become stem cells by simply exposing them to chemical solutions (mostly acidic) or physical stress. Stem cells can be manipulated to develop into any of the bodys tissues to repair or replace diseased cells.

The controversy erupted when Obokata and her team published a tips sheet for other researchers to follow to replicate their work. But inconsistencies between the newly released methods and the original protocol in the papers, as well as questions about images in the published work, led some to wonder about the validity of the results. Wakayama himself said he was able to repeat the study only once, with Obokatas assistance, but not on his own.

MORE: The Rise and Fall of the Cloning King

In a press conference in Japan last month, Wakayama, who is best known for using stem cell techniques to clone mice, said he asked all of the scientists involved to retract the papers, which were published in the journal Nature in January, and to have the data and results reviewed by other scientists. RIKEN is investigating the work, as is Nature.

The development adds another black eye to the field of stem cell science, which is ripe with possibility but has struggled to establish its credibility. In 2006, Korean researcher Woo Suk Hwang claimed he had become the first to successfully clone human cells, generating patient-specific lines of stem cells from a persons skin cell. The work turned out to be fraudulent, and the stem cells derived from an already established technique of extracting them from existing embryos.

Since then, both policy makers and those in the field have been more skeptical of milestone claims for good reason, as the latest study shows.

Originally posted here:
Stem Cell Researcher Calls for Retraction of His Own Work

Harvard scientists have made a breakthrough in studying early onset Alzheimers Disease by converting patients skin cells into neurons in the hopes of facilitating a better understanding of the disease and creation of drug therapies.

The study, led by Tracy Young-Pearse, a Harvard Stem Cell Institute affiliate and member of Brigham and Womens hospital, concluded what had previously only been observed in micethat the early onset of Alzheimers is directly correlated to higher levels of amyloid beta protein 42. Most people generally produce amyloid beta with only 40 amino acids, but in early onset of the disease, amyloid beta protein 42, which has two extra amino acids, was more prevalent.

As a form of progressive dementia that affects more than 26 million people worldwide, early onset AD usually brings about cognitive decline and memory loss in individuals in their 30s to 50s while the more common late onset AD tends to affect individuals in their 70s, 80s and 90s.

Researchers also concluded that the neurons had higher amounts of tau protein, a classic signal of Alzheimers presence.

The recent findings could lead to the development of potential therapies for this common disease.

The ability to direct stem cells generated from patients to become brain cells allows us with an unprecedented opportunity to study, on a large scale, living patient-derived brain cells in a dish, Young-Pearse said. Not only can we use these to better understand the mechanisms underlying the disease, but we also can use these to test novel therapeutic strategies in the cell types involved in the disease.

Moreover, this research serves as a proof-of-concept that stem cells can be used to model diseases and discover therapies.

The field is highly collaborative, working together to[make] different types of neurons that are affected in various neurodegenerative diseases including Parkinson's, ALS, Huntington's and Alzheimer's disease, Young-Pearse said.

Staff writer Arjun S. Byju can be reached at arjun.byju@thecrimson.com.

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Researchers Find Novel Methods to Study Alzheimer's

Mouse cells exposed to an acidic environment turned into embryonic-like "STAP" cells. These were used to generate an entire fetus.

A coauthor of a disputed study on a new way generating stem cells through exposure to acid and other stresses has asked for its retraction, it was reported Monday.

Teruhiko Wakayama asked for retraction of two papers describing so-called STAP cells, according to the Yomiuri Shimbun. The papers had been published in the Jan. 30 edition of the journal Nature. Other news outlets, including the Wall Street Journal and the Boston Globe, quickly followed up with the call for retraction.

The original announcement gained worldwide attention because it promised an easy way to generate pluripotent stem cells, which act like embryonic stem cells. Simply immersing cells in an acid bath or squeezing them was enough to reprogram them to the embryonic-like state, the scientists reported. The acronym STAP stands for stimulus-triggered acquisition of pluripotency.

However, researchers attempting to replicate the experiment, including those at the Salk Institute and The Scripps Research Institute in La Jolla, have so far reported failure. And errors in the papers, including duplication of images, have caused scientists to question the findings.

The first author of both papers is Haruko Obokata, 30, of the Riken Center for Developmental Biology in Japan. She was hailed as a scientific prodigy after the research was published. Another coauthor, Charles Vacanti, chairman of the Anesthesiology department at Brigham and Womens Hospital in Boston, had previously said the errors were caused by overwork and didn't affect the results.

As recently as Feb. 27, Wakayama said scientists should give replication efforts a year before passing judgment.

But on Monday, Wakayama said the irregularities render the findings questionable.

"Wakayama said images that show pluripotency of STAP cells look almost identical to those used in Obokatas doctoral thesis about pluripotent stem cells that exist in human body," the Yomiuri Shimbun reported.

Wakayama is probably acting out of a sense of duty, said Jeanne Loring, a stem cell scientist at The Scripps Research Institute.

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STAP cells paper coauthor asks for retraction

By Maggie Fox

One of the worlds leading stem cell experts has suggested withdrawing a study that made global headlines last January, saying he has questions about some of the images and data in it.

The Japanese team, led by Teruhiko Wakayama, reported that they had created powerful stem cells by doing little more than soaking ordinary cells in an acid solution.

The report, published in the journal Nature, impressed other stem cell researchers and opened the possibility of an easy approach to regenerative medicine. But Japanese television quotes Wakayama as saying he wants to take a closer look.

"When conducting the experiment, I believed it was absolutely right, Reuters news agency quotes Wakayama as telling the television station NHK.

"But now that many mistakes have emerged, I think it is best to withdraw the research paper once and, using correct data and correct pictures, to prove once again the paper is right," he said.

"If it turns out to be wrong, we would need to make it clear why a thing like this happened."

But Charles Vacanti of Harvard Medical School and Brigham and Women's Hospital in Boston, who helped work on the study, said he disagreed. "Some mistakes were made, but they don't affect the conclusions," the Wall Street Journal quoted him as saying.

"Based on the information I have, I see no reason why these papers should be retracted."

Stem cell researchers may be more sensitive than other scientists. In 2006, Seoul National University fired Hwang Woo-Suk after the journal Science retracted two papers he wrote claiming to have cloned human embryos and extracted stem cells from them.

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Stem Cell Researcher Suggests Recalling His Own Study

The recent news of veteran TV journalist Tom Brokaw being diagnosed with multiple myeloma sparked interest in this rare form of cancer. Approximately 20,000 people are diagnosed annually with multiple myeloma cancer of the plasma cells in the bodys bone marrow. These abnormal plasma cells dont produce antibodies, so the immune system cant fight off infections.

Like Brokaw, who is 74, the majority of people diagnosed with multiple myeloma as well as more common blood cancers such as leukemia and lymphoma are older than 65. That means that many of these patients depend on Medicare to pay for their treatment, which often includes a blood or bone marrow transplant (BMT).

Ten years ago, patients older than 55 were commonly excluded from this treatment option. Today, because of medical advances, the Medicare population is the fastest-growing segment of patients in most BMT programs in the United States.

However, because of Medicare coverage restrictions, many patients who need a transplant are unable to receive treatment unless they are in the financial position to pay privately for their care.

The financial burden is even more significant when a transplant requires the use of donated stem cells, often needed for those with blood cancers such as leukemia and lymphoma. Because of a difference in the way that Medicare reimburses hospitals for BMT in comparison with solid organ transplantation, each BMT using donor cells results in a substantial financial loss to the hospital providing care.

The financial loss per transplant case is large enough that it is unsustainable, cannot be offset by private insurance payments and is threatening our ability to continue to deliver this vital therapy to those who need it most.

Our clinical success in finding ways to treat older patients has created an unfortunate, but very real, financial threat to the continued existence of our field. In December, we began a dialogue with our partners at Medicare to remedy this situation and hope that continued discussions will result in a correction of the rate-setting methodology currently used.

We are mindful that BMT is an expensive therapy. There is no question that expert teams and significant resources are required. But it is also a lifesaving therapy. Currently, there are more than 100,000 transplant survivors in the United States. With continuing advances in the use of transplant, we project 250,000 by 2020 and 500,000 by 2030 with a quarter of the survivors being over 60 years old.

These costs would not disappear if this treatment were not available. The costs of providing alternate therapies that do not have the potential to be curative are significant. Older patients deserve continued access to therapies that will provide them with the best chance of enjoying more well-earned years of high-quality life with their families and friends.

This month, the American Society for Blood and Marrow Transplantation (ASBMT) celebrates 20 years since its founding. We represent nearly 2,000 transplant clinicians and health care professionals worldwide. Recently we gathered in Dallas for our annual meeting to share cutting-edge research and knowledge, continuing our quest to be the best in the world at what we do for the sake of our patients.

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Blood, marrow transplants must be kept accessible

San Diego, CA (PRWEB) March 10, 2014

Histogen Aesthetics, a subsidiary of regenerative medicine company Histogen, Inc. focused on skin care and cosmeceuticals, announced today that the Company has acquired the CellCeuticals Biomedical Skin Treatments line of skincare products.

Histogen Aesthetics will continue sales of the eleven existing CellCeuticals Biomedical Skin Treatments skincare products, while bringing new innovation to the line through the addition of a unique regenerative medicine technology, working to improve skin aging at a cellular level.

We have long admired the science, clinical data and elegant formulas behind the CellCeuticals line, and see it as an ideal fit for our recently revitalized aesthetics subsidiary, said Dr. Gail K. Naughton, CEO and Chairman of Histogen, Inc. We are very excited to begin infusing unique cell-signaling factors into the CellCeuticals regimen, to truly transform skin one cell at a time.

Dr. Naughton has spent more than 30 years in tissue engineering and regenerative medicine, and holds over 100 patents in the field. She founded Histogen in 2007, focused on developing therapies that work to stimulate the stem cells in the body to regenerate tissues and organs. Through this work, she has also seen how different compositions of human proteins can have cosmetic benefits, particularly in anti-aging and rejuvenation.

I am pleased that the CellCeuticals Biomedical Skin Treatments will evolve, and see Histogen Aesthetics as an excellent home for this innovative product line, said Paul Scott Premo, co-founder of CellCeuticals Skin Care, Inc. I believe the addition of this regenerative medicine technology will be the opportunity to introduce a new generation of products that are the vanguard of regenerative skin care.

The CellCeuticals system is made up of eleven distinctive products including the Extremely Gentle Skin Cleanser, CellGenesis Regenerative Skin Treatment, and PhotoDefense Color Radiance SPF55+ with proprietary and patented PhotoPlex technology. The line is currently available at retailers including QVC.com, Dermstore.com, and Nordstrom.com, as well as http://www.cellceuticalskincare.com.

About Histogen Aesthetics Histogen Aesthetics LLC, formed in 2008 as a subsidiary of Histogen, Inc., focuses on the development of innovative skin care products utilizing regenerative medicine technology. Histogen Aesthetics technology is based on the expertise of founder Dr. Gail K. Naughton, in which fibroblasts are grown under unique conditions, producing a complex of naturally-secreted proteins and synergistic bio-products known to stimulate skin cells to regenerate and rejuvenate tissues. In 2014, Histogen Aesthetics acquired CellCeuticals Biomedical Skin Treatments, a line of scientifically-proven products that reactivate cells to help aging skin perform and look healthier and younger. For more information, visit http://www.cellceuticalskincare.com.

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process is also being researched for oncology applications, and in orthopedics through joint venture PUR Biologics, LLC. For more information, please visit http://www.histogen.com.

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Histogen Aesthetics Acquires CellCeuticals Biomedical Skin Treatments

PUBLIC RELEASE DATE:

9-Mar-2014

Contact: Henry Rummins h.rummins@ucl.ac.uk 44-207-679-9063 University College London

Japanese pharmaceutical company Takeda will work with University College London (UCL) to drive research into tackling muscle disorders, in particular muscular dystrophy.

The research which is being conducted by the research group of Dr Francesco Saverio Tedesco is being supported through funding of $250,000 from the company's New Frontier Sciences group. Takeda's NFS aims to support innovative, cutting-edge research which could eventually lead to drug discovery and development.

Dr Tedesco's team will focus on the study of muscular regeneration and the potential for stem cell therapies to treat muscular dystrophy, in particular induced pluripotent (iPS) stem cells.

The team is also investigating the potential for treating muscular dystrophy through developing novel gene and cell therapy strategies using artificial human chromosomes and novel biomaterials.

Using this approach, Dr Tedesco hopes to overcome a number of current limitations to developing effective treatments for muscular dystrophies. It is hoped that through the use of these modified stem cells, large quantities of progenitor cells could be produced to be transplanted into a patient's muscle following genetic correction or to be used for drug development platforms.

Importantly, the team will attempt to produce these cells which can be applied more easily in a clinical context, in order to reduce the hurdles that might limit their possible future use in clinical studies.

Through previous work using a mouse model of Duchenne muscular dystrophy, the team has already demonstrated the potential of pre-clinical gene replacement therapy using an artificial human chromosome.

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Takeda and UCL to work together to tackle muscle disorders