Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the clinical effects of Stemedyne-MSC (Stemedicas human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with a myocardial infarct.

San Diego, CA (PRWEB) October 02, 2012

The clinical trial will address the prevalence of cardiovascular disease estimated to carry a global disease burden in excess of $400 billion each year. More than one million patients undergo PTCA and stenting in the Untied States annually; another 800,000 have the procedures each year in Europe.

Nabil Dib, M.D., MSc., F.A.C.C., Director of Cardiovascular Research at Mercy Gilbert and Chandler Regional Medical Centers, and an Associate Professor of Medicine and Director of Clinical Cardiovascular Cell Therapy at the University of California, San Diego, will serve as the principal investigator of the FDA-approved study. Dr. Nib commented, We've learned from bench top research that not all stem cells are created equally. We believe that the ischemic tolerance of Stemedica's MSCs and the robustness of their protein array will translate into significant patient benefits post myocardial infarction.

Stemedicas interest in this indication was triggered by a successful randomized study in acute myocardial infarction conducted by the National Scientific Medical Center (NSMC) in Astana, Kazakhstan using Stemedyne-MSCs. The study was conducted under clinical protocol and in compliance with the ICH-E6 (Good Clinical Practice) guidelines and local laws. All patients signed an informed consent. Nineteen (19) patients in this study received Stemedyne-MSCs after PTCA and stenting. Administration of Stemedyne-MSC resulted in a statistically-significant decrease in inflammation as judged by the level of C-reactive protein, significant decrease in end-systolic and end-diastolic volume of left ventricle, as well as significant increase in the left ventricular ejection fraction (LVEF) from 38.4% to 54.7% at 6 months post administration, bringing this parameter to a normal range for healthy individuals (50-65%).

Professor Daniyar Jumaniyazov, M.D. Ph.D., principal investigator of the NSMC study commented, The stem cell transplantation was safe and the procedure was well tolerated. No product-related adverse events were reported. Treatment of patients in this study resulted in improvement of overall and local contractive myocardium functions and also normalization of systolic and diastolic filling of the left ventricle as compared to the control group. Based upon the safety and efficacy results, we will soon conduct a Phase III myocardial infarct clinical trial at the NSMC with Stemedicas ischemia tolerant mesenchymal stem cells.

Lev Verkh, Ph.D., Stemedica Chief Regulatory and Clinical Development Officer commented, Stemedicas FDA submission included data from the NSMC clinical trial, the results of which were also reported at the annual American College of Cardiology meeting in April, 2012. These results contrasted with reports, at the same conference, of minimal improvement in studies with autologous stem cells. In addition to the United States sites, the study will be duplicated at leading hospitals in Europe, Asia and the Middle East. With regard to the spectrum of stem cell treatment for cardiovascular disease, Dr. Verkh noted that, Stemedyne-MSC has been approved for the treatment of chronic heart failure at Hospital Angeles, Tijuana, Mexico by COFEPRIS (the Mexican equivalent of the FDA).

Jackie See, M.D., F.A.C.C., founder of interventional cardiology at the University of California, Irvine, noted, "In the days and weeks following a myocardial infarction we may have the ability to intervene with stem cells to minimize scarring, enhance the amount of functional heart tissue, and restore the microcirculation. Stemedica's ischemia tolerant mesenchymal stem cells are ideal for this purpose. I can foresee the day when all coronary stenting is accompanied by stem cell injection. It is not unreasonable to postulate that the anti-inflammatory and anti-fibrotic effects of the mesenchymal stem cells may have an impact on the incidence of restenosis, a common condition caused by blockage of the stents.

The Stemedyne-MSC product is uniquely manufactured to contain increased amounts of the important growth factors that combat ischemic damage. According to Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica, Our ischemia tolerant MSCs secrete increased amounts of vascular endothelial growth factor (VEGF), which is necessary for new blood vessel development and stromal cell-derived factor (SDF), which is responsible for rescuing dying cells. Stemedyne-MSCs also demonstrate significantly higher migratory abilities. As a company we are unique in our unparalleled scalability, with our master bank at two passages and the cells that go into patients having only been expanded four times. We have the ability to treat more than 500,000 patients with cells created from a single organ donation.

Stemedyne-MSC is one of the three adult allogeneic stem cell products developed by the Company. Other products include Stemedyne-NSC neural human stem cells and Stemedyne-RPE, retinal progenitor epithelial cells available in early 2013. All Stemedica products are unique in their ability to tolerate ischemic conditions.

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FDA Approves Stemedica Phase II Clinical Trial For Acute Myocardial Infarction With Ischemia Tolerant Mesenchymal Stem ...

DENVER - Can you imagine having a family member who's diagnosed with a disease and no one in your family, including yourself, is a match to donate.

That's the reality for 70 percent of patients needing bone marrow or stem cells. They have no other choice but to go through the bone marrow registry.

Those families rely on complete strangers who are willing to donate whatever they can in hope of saving someone's life.

One of those donors is Aurora resident Denise Camacho. She joined the bone marrow registry never thinking that anything would ever come of it.

"I have a family friend that works with Bonfils," Camacho said. "She emailed me and my family and said there's a huge need for minorities to join the registry. So we went down not knowing anyone of us would ever be called."

But just two years later, she was called to make a donation.

"I got a phone call that I'm a match, but I need to go in for further testing. All they told me was that there was a 13-year-old boy in Cleveland who has leukemia." Camacho said. "How do you say 'no' when there's a family out there that you can help and possibly save a life. I was going to do what I could."

That 13-year-old boy was Enrique Linares. He was diagnosed with acute lymphoblastic leukemia.

His entire family, 38 people in all, were tested to be a donor but none of them were a match.

After nearly two years, spent mostly in the hospital, there was a match. It was a match no one expected. Camacho is unrelated and has a different blood type.

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Bone marrow donor meets recipient

GRANTS PASS This month, Jerry Condit met the only man in the world who could and did save his life.

Condit needed a stem cell transplant to replace bone marrow lost to leukemia, a blood-attacking cancer diagnosed in January 2008 on his 69th birthday.

Doctors estimated he had two years to live if it went untreated. But finding a suitable donor was difficult. In fact, the National Marrow Donor Program says only about half of the people in need of transplants ever find a donor.

After searching national and international registries of millions of potential donors, doctors found only one match: Marco Rixen, a 34-year-old resident of Germany.

He matched 11 of the 12 markers they were looking for, said Condits wife, Jan. It was enough to consider Rixen a match.

The transplant was performed in May 2008 at Oregon Health & Science University in Portland. Rixen made his donation at a medical center in Germany, where a courier rushed the stem cells to a plane bound for Portland. Less than 36 hours later, Condits transfusion was under way.

For the first two years after the transplant, Condit and Rixen could communicate only through the bone marrow donation agency. After that, names and e-mail addresses were released.

The two kept in touch, and one day the Condits got a message from Rixen that said he was planning to visit the United States.

I didnt know if I would ever get the chance to meet him, said Condit, who cant travel because of his vulnerable immune system. He wrote us and said he was coming here, and we just about fell over.

Rixen and his wife, Anja, spent Sept. 19 with the Condits in Grants Pass before heading to Las Vegas to renew their wedding vows in front of an Elvis impersonator and then visit the Grand Canyon.

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Grants Pass man meets donor who saved his life

A 10-year-old boy has been infused with stem cells harvested from the bone marrow of his brother to treat him for thalassaemia a disorder caused by destruction of red blood cells. Called allogeneic transplantation of stem cells, this was done at Kovai Medical Center and Hospital.

D. Dhanush may not have to undergo expensive and excruciating blood transfusion anymore if his body accepts the donor cells. But his condition will have to be evaluated very minutely for the next two years to confirm that the cells donated by his brother have been received well and adapted him.

Presenting the boy before media persons, Clinical Haematologist and Head of the Bone Marrow Transplant Unit T. Rajasekar explained that transplantation was of two types autologous and allogeneic.

The autologous procedure involves harvesting of stem cells from the patients themselves (those suffering from thalassaemia or leukaemia). The extracted cells are frozen and stored for high dose treatment.

After being treated, these are infused into the patient through a vein. This procedure was done for one person suffering from myeloma (cancer of plasma cells or white blood cells that produce anti-bodies that help fight infections/diseases) and another with a relapsed lymphoma (cancer of the lymphocytes cells that are part of immune system).

Under the allogeneic procedure, matching stem cells from a donor are used. Mostly, these cells are from siblings or a close relative as they need to pass the human leukocyte antigen (HLA) matching test. HLA matching is required, or the cells will be rejected by the recipient. Ideally, it is sibling whose cells will match because he or she will have the HLA from both parents. It is the combination of HLAs from both parents that are found in the children.

The cells can be harvested from the marrow or from the blood. In the case presented on Tuesday, Dr. Rajasekar said the cells were brought out of the bone marrow in Dhanushs brother and into his blood, from where these were harvested.

Chairman of the hospital Nalla G. Palaniswami said the tough procedure was performed by the new Comprehensive Cancer Centre, which was gradually bringing in specialists of all sub-specialities of cancer care. Only then can this be called a comprehensive centre, he said.

The hospital would form a KMCH Foundation, which would use funds from donors to treat poor children suffering from cancer and some other disorders that required expensive treatment.

The stem cell transplantation that Dhanush, the son of a police head constable, underwent cost Rs.12 lakh. Of this, Rs.9 lakh was provided by a donor, Dr. Palaniswami said. Dean of the hospital V. Kumaran and Head of Department of Interventional Radiology Mathew Cherian spoke on how the cancer centre was established and how developments were being made.

Read more from the original source:
Stem cell transplantation for boy with thalassaemia

ScienceDaily (Sep. 11, 2012) By including chemotherapy as a conditioning regimen prior to treatment, researchers have developed a refined gene therapy approach that safely and effectively restores the immune system of children with a form of severe combined immunodeficiency (SCID), according to a study published online September 11 in Blood, the Journal of the American Society of Hematology (ASH).

SCID is a group of rare and debilitating genetic disorders that affect the normal development of the immune system in newborns. Infants with SCID are prone to serious, life-threatening infections within the first few months of life and require extensive treatment for survival beyond infancy.

Adenosine deaminase (ADA) deficiency, which accounts for approximately 15 percent of all SCID cases, develops when a gene mutation prohibits the production of ADA, an enzyme that breaks down toxic molecules that can accumulate to harmful levels and kill lymphocytes, the specialized white blood cells that help make up the immune system. In its absence, infants with ADA-deficient SCID lack almost all immune defenses and their condition is almost always fatal within two years if left untreated. Standard treatment for ADA-deficient SCID is a hematopoietic stem cell transplant (HSCT) from a sibling or related donor; however, finding a matched donor can be difficult and transplants can carry significant risks. An alternate treatment method, enzyme replacement therapy (ERT), involves regular injections of the ADA enzyme to maintain the immune system and can help restore immune function; however, the treatments are extremely expensive and painful for the young patients and the effects are often only temporary.

Given the limitations of HSCT and ERT, in the 1990s researchers began investigating the efficacy of gene therapy for ADA-deficient SCID. They discovered that they could "correct" the function of a mutated gene by adding a healthy copy into the cells of the body that help fight infectious diseases. Since then, there have been significant advances in gene therapy for SCID, yet successful gene therapy in patients with ADA-deficient SCID has been seen in only a small series of children due to the difficulty of introducing a healthy ADA gene into bone marrow stem cells and to engraft these cells back into the patients.

"Although the basic steps of gene therapy for patients with SCID have been known for a while, technical and clinical challenges still exist and we wanted to find an optimized gene therapy protocol to restore immunity for young children with ADA-deficient SCID," said Fabio Candotti, MD, one of the study's senior authors, senior investigator in the Genetics and Molecular Biology Branch of the National Human Genome Research Institute at the National Institutes of Health, and chair of the ASH Scientific Committee on Immunology and Host Defense.

To determine whether an enhanced gene therapy approach would improve immunity in children with ADA-deficient SCID, the teams of Dr. Candotti and Donald B. Kohn, MD, director of the Human Gene Medicine Program at the University of California, Los Angeles (UCLA), Professor of Pediatrics and of Microbiology, Immunology, and Molecular Genetics, and a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, conducted a clinical trial in 10 patients with the disorder. For the first time, Drs. Candotti and Kohn and their team of investigators compared two different retroviral vectors, MND-ADA and GCsapM-ADA, to transport normal ADA genes into the young patients' bone marrow stem cells as well as two different treatment plans in preparation for receiving gene therapy. Following therapy, investigators found that more bone marrow stem cells were marked with the MND-ADA vector, demonstrating its superiority over the GCsapM-ADA vector.

The investigators also sought to determine whether providing a low dose of chemotherapy prior to gene therapy, known as a pre-transplant conditioning regimen, would successfully deplete the young patients' bone marrow stem cells and make room for gene-corrected stem cells. In four patients, gene therapy was performed without chemotherapy, and the patients remained on ERT throughout the entire procedure to evaluate the efficiency of ERT combined with gene therapy. While these patients did not experience any adverse effects, they also did not experience a significant increase in their levels of the ADA enzyme. They also maintained low absolute lymphocyte counts (ALC) and minimal immune system function, leading the researchers to believe that ERT may weaken the therapy's effect by diluting the number of gene-corrected lymphocytes.

The remaining six patients were treated with the chemotherapy drug busulfan prior to gene therapy and ERT was discontinued prior to the gene therapy procedure. A significant increase in ADA was observed in all six patients; half of them remain off of ERT with partial immune reconstitution -- findings that support results from prior trials in Italy and the United Kingdom using chemotherapy prior to gene therapy and discontinuting ERT. While the ALC of all six patients declined sharply in the first few months due to combined effects of busulfan administration and ERT withdrawal, their counts increased from six to 24 months, even in the three patients that remained off of ERT. After adjusting the chemotherapy dosage, investigators were able to determine an optimal level for enhancing the efficacy of the gene-therapy-corrected cells with minimal toxicity.

This study is the first to detail comparisons of ADA-deficient SCID patient outcomes between those treated with gene therapy who have not received pre-transplant conditioning while continuing to receive ERT with those receiving pre-transplant conditioning without the administration of ERT. This study is also the first to compare two different viral vectors to transport normal ADA genes into patient bone marrow.

"We were very happy that in this trial we were able to see a benefit in the patients after we modified the protocol," said Dr. Kohn. "Doctors treating ADA-deficient SCID have had too few options for too long, and we hope this will provide them with an efficient and effective treatment for this devastating disease."

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Gene therapy technique for children with immune disorder improved

Researchers have discovered a cell that is the "missing link" between bone marrow stem cells and all the cells of the human immune system, according to a release from the University of California, Los Angeles. This finding promises to lead to a more profound understanding of how a healthy immune system is created and as well as how disease can cause poor immune function.

The study's senior author, Dr. Gay Crooks, was quoted as saying, " We felt it was especially important to do these studies using human bone marrow, as most research into the development of the immune system has used mouse bone marrow.The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of post-natal life."

Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, cancers of the blood. The findings were published online in the journal Nature Immunology.

"The identification of a progenitor in human bone marrow primed for full lymphoid differentiation will now permit delineation of the molecular regulation of the first stages of lymphoid commitment in human hematopoiesis," the authors wrote. "It will also allow understanding of how these processes are affected during aberrant hematopoiesis in disease states."

Continued here:
Stem Cells & Immune System: "Missing Link" Found

LOS ANGELES UCLA researchers have discovered a type of cell that is the "missing link" between bone marrow stem cells and all the cells of the human immune system, a finding that will lead to a greater understanding of how a healthy immune system is produced and how disease can lead to poor immune function.

The research was done using human bone marrow, which contains all the stem cells that produce blood during post-natal life.

"We felt it was especially important to do these studies using human bone marrow, as most research into the development of the immune system has used mouse bone marrow," said the study's senior author, Dr. Gay Crooks, co-director of UCLA's Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and a co-director of the cancer and stem-cell biology program at UCLA's Jonsson Comprehensive Cancer Center. "The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of post-natal life."

The research team was "intrigued to find this particular bone marrow cell, because it opens up a lot of new possibilities in terms of understanding how human immunity is produced from stem cells throughout life," said Crooks, a professor of pathology and pediatrics.

Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, cancers of the blood.

The findings appeared Sept. 2 in the early online edition of the journal Nature Immunology.

Before this study, researchers had a fairly good idea of how to find and study the blood stem cells of the bone marrow. The stem cells live forever, reproduce themselves and give rise to all the cells of the blood. In the process, the stem cells divide and produce cells in intermediate stages of development called progenitors, which make various blood lineages, like red blood cells or platelets.

Crooks was most interested in the creation of the progenitors that form the entire immune system, which consists of many different cells called lymphocytes, each with a specialized function to fight infection.

"Like the stem cells, the progenitor cells are also very rare, so before we can study them, we needed to find the needle in the haystack," said Lisa Kohn, a member of the UCLA Medical Scientist Training Program and first author of the study.

Previous work had found a fairly mature type of lymphocyte progenitor with a limited ability to differentiate, but the new work describes a more primitive type of progenitor primed to produce the entire immune system, Kohn said.

Continued here:
'Missing link' ties blood stem cells, immune system

ScienceDaily (Aug. 31, 2012) UCLA researchers have discovered a type of cell that is the "missing link" between bone marrow stem cells and all the cells of the human immune system, a finding that will lead to a greater understanding of how a healthy immune system is produced and how disease can lead to poor immune function.

The studies were done using human bone marrow, which contains all the stem cells that produce blood during postnatal life.

"We felt it was especially important to do these studies using human bone marrow as most research into the development of the immune system has used mouse bone marrow," said study senior author Dr. Gay Crooks, co-director of the Eli and Edythe Broad Center of Regenerative Medicine and a co-director of the Cancer and Stem Cell Biology program at UCLA's Jonsson Comprehensive Cancer Center. "The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of postnatal life."

The research team was "intrigued to find this particular bone marrow cell because it opens up a lot of new possibilities in terms of understanding how human immunity is produced from stem cells throughout life," said Crooks, a professor of pathology and pediatrics.

Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, or cancers of the blood.

The study appears Sept. 2 in the early online edition of Nature Immunology.

Before this study, researchers had a fairly good idea of how to find and study the blood stem cells of the bone marrow. The stem cells live forever, reproduce themselves and give rise to all the cells of the blood. In the process, the stem cells divide and produce intermediate stages of development called progenitors, which make various blood lineages like red blood cells or platelets. Crooks was most interested in the creation of the progenitors that form the entire immune system, which consists of many different cells called lymphocytes, each with a specialized function to fight infection.

"Like the stem cells, the progenitor cells are also very rare, so before we can study them we needed to find the needle in the haystack." said Lisa Kohn, a member of the UCLA Medical Scientist Training Program and first author in the paper.

Previous work had found a fairly mature type of lymphocyte progenitor with a limited ability to differentiate, but the new work describes a more primitive type of progenitor primed to produce the entire immune system, Kohn said

Once the lymphoid primed progenitor had been identified, Crooks and her team studied how gene expression changed during the earliest stages of its production from stem cells.

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'Missing link' between stem cells and the immune system

Public release date: 2-Sep-2012 [ | E-mail | Share ]

Contact: Kim Irwin kirwin@mednet.ucla.edu 310-206-2805 University of California - Los Angeles Health Sciences

UCLA researchers have discovered a type of cell that is the "missing link" between bone marrow stem cells and all the cells of the human immune system, a finding that will lead to a greater understanding of how a healthy immune system is produced and how disease can lead to poor immune function.

The studies were done using human bone marrow, which contains all the stem cells that produce blood during postnatal life.

"We felt it was especially important to do these studies using human bone marrow as most research into the development of the immune system has used mouse bone marrow," said study senior author Dr. Gay Crooks, co-director of the Eli and Edythe Broad Center of Regenerative Medicine and a co-director of the Cancer and Stem Cell Biology program at UCLA's Jonsson Comprehensive Cancer Center. "The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of postnatal life."

The research team was "intrigued to find this particular bone marrow cell because it opens up a lot of new possibilities in terms of understanding how human immunity is produced from stem cells throughout life," said Crooks, a professor of pathology and pediatrics.

Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, or cancers of the blood.

The study appears Sept. 2 in the early online edition of Nature Immunology.

Before this study, researchers had a fairly good idea of how to find and study the blood stem cells of the bone marrow. The stem cells live forever, reproduce themselves and give rise to all the cells of the blood. In the process, the stem cells divide and produce intermediate stages of development called progenitors, which make various blood lineages like red blood cells or platelets. Crooks was most interested in the creation of the progenitors that form the entire immune system, which consists of many different cells called lymphocytes, each with a specialized function to fight infection.

"Like the stem cells, the progenitor cells are also very rare, so before we can study them we needed to find the needle in the haystack." said Lisa Kohn, a member of the UCLA Medical Scientist Training Program and first author in the paper.

See the rest here:
UCLA researchers discover missing link between stem cells and immune system

Newswise UCLA researchers have discovered a type of cell that is the missing link between bone marrow stem cells and all the cells of the human immune system, a finding that will lead to a greater understanding of how a healthy immune system is produced and how disease can lead to poor immune function.

The studies were done using human bone marrow, which contains all the stem cells that produce blood during postnatal life.

We felt it was especially important to do these studies using human bone marrow as most research into the development of the immune system has used mouse bone marrow, said study senior author Dr. Gay Crooks, co-director of the Eli and Edythe Broad Center of Regenerative Medicine and a co-director of the Cancer and Stem Cell Biology program at UCLAs Jonsson Comprehensive Cancer Center. The few studies with human tissue have mostly used umbilical cord blood, which does not reflect the immune system of postnatal life.

The research team was intrigued to find this particular bone marrow cell because it opens up a lot of new possibilities in terms of understanding how human immunity is produced from stem cells throughout life, said Crooks, a professor of pathology and pediatrics.

Understanding the process of normal blood formation in human adults is a crucial step in shedding light on what goes wrong during the process that results in leukemias, or cancers of the blood.

The study appears Sept. 2 in the early online edition of Nature Immunology.

Before this study, researchers had a fairly good idea of how to find and study the blood stem cells of the bone marrow. The stem cells live forever, reproduce themselves and give rise to all the cells of the blood. In the process, the stem cells divide and produce intermediate stages of development called progenitors, which make various blood lineages like red blood cells or platelets. Crooks was most interested in the creation of the progenitors that form the entire immune system, which consists of many different cells called lymphocytes, each with a specialized function to fight infection.

Like the stem cells, the progenitor cells are also very rare, so before we can study them we needed to find the needle in the haystack. said Lisa Kohn, a member of the UCLA Medical Scientist Training Program and first author in the paper.

Previous work had found a fairly mature type of lymphocyte progenitor with a limited ability to differentiate, but the new work describes a more primitive type of progenitor primed to produce the entire immune system, Kohn said

Once the lymphoid primed progenitor had been identified, Crooks and her team studied how gene expression changed during the earliest stages of its production from stem cells.

Read the original here:
UCLA Researchers Discover "Missing Link" Between Stem Cells and the Immune System

Featured Article Academic Journal Main Category: Bones / Orthopedics Also Included In: Stem Cell Research Article Date: 23 Aug 2012 - 11:00 PDT

Current ratings for: Osteoporosis Clue Found In Stem Cell Signalling Protein

1 (1 votes)

These are the implications of a new study led by Harvard Medical School (HMS) that was published online in The Journal of Clinical Investigation on 13 August.

Senior author Bjorn Olsen, Hersey Professor of Cell Biology at HMS, told the press about what they found:

"It shifts the thinking about what controls the differentiation of stem cells to bone cells instead of fat cells, and how to make sure this mechanism stays active with aging."

Bone is not a dead material: it is living tissue that is changing all the time, as it is continuously formed and reabsorbed.

Osteoporosis is a common bone disease where bone tissue becomes progressively thinner, resulting in higher risk of fracture. It affects about 1 in 5 American women and is thought to be caused by stem cells that normally differentiate into bone-forming cells becoming fat cells instead over time.

For the study, Olsen, who is professor of developmental biology and dean for research at Harvard School of Dental Medicine, and colleagues, decided to investigate the role of vascular endothelial growth factor, or VEGF, a common signalling protein that plays a key role in the development of blood vessels that are important in early bone growth and skeletal maintenance in mammals. The protein works by activating receptors on the surface of cells.

Soon after they were born, the mice's skeletons began to show osteoporosis-like qualities, such as reduced bone tissue and a build up of fat in the bone marrow.

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Osteoporosis Clue Found In Stem Cell Signalling Protein

Some worry that a ruling giving donors the ability to sell their bone-marrow tissue will encourage legal sale of other body parts.

STORY HIGHLIGHTS

(Time.com) -- How much would it take for you to consider selling your bone marrow? A U.S. appeals court puts the price at about $3,000 in a ruling that now makes it legal to pay donors for their bone-marrow tissue.

The court's decision may well help thousands of sick patients who need bone-marrow transplants to survive, but it also begs the question, What other body parts might next be up for sale?

The ruling came about at the end of 2011, in a decision to an October 2009 lawsuit brought by a group of cancer patients, parents and bone-marrow-donation advocates against the government over the federal law banning the buying and selling of bodily organs. The plaintiffs were led by Doreen Flynn, who has three daughters who suffer from Fanconi anemia, a blood disorder that requires bone-marrow transplants to treat.

Flynn and the other plaintiffs said that too many such patients die waiting for transplants and argued that we should be allowed to pay people to donate their marrow as a way of ensuring a more reliable supply. The U.S. Court of Appeals for the Ninth Circuit agreed.

Time.com: Facebook now lets organ donors tell their friends

At the core of the plaintiffs' argument was the National Organ Transplantation Act (NOTA), which since 1984 has forbid the buying and selling of human organs, including bone marrow. But new developments in bone-marrow extraction have made marrow donation not much different from donating blood.

Traditionally, bone-marrow donation required anesthesia and long needles to extract the marrow from the hip bones of donors. Now, a technique called peripheral apheresis allows doctors to extract blood stem cells directly from the blood, instead of the bone -- patients first take a drug that pulls stem cells from the bone and into the blood -- meaning that the marrow cells should be considered a fluid like blood, rather than an organ, the plaintiffs argued. NOTA doesn't prohibit payments for blood or other fluids, such as plasma or semen.

U.S. Attorney General Eric Holder decided not to ask the Supreme Court to review the appellate court's decision, which would have been the next step in overturning it. That means the ruling stands -- and that people can now be paid up to $3,000 for their marrow, as long as it is collected by apheresis. In a concession to the spirit of NOTA, however, the compensation can't be in cash; it needs to be in the form of a voucher that can be applied to things such as scholarships, education, housing or a donation to a charity.

Read more here:
Should you be allowed to sell organs?

ScienceDaily (July 3, 2012) searchers from the University of Maryland School of Maryland report promising results from using adult stem cells from bone marrow in mice to help create tissue cells of other organs, such as the heart, brain and pancreas -- a scientific step they hope may lead to potential new ways to replace cells lost in diseases such as diabetes, Parkinson's or Alzheimer's.

The research in collaboration with the University of Paris Descartes is published online in the June 29, 2012 edition of Comptes Rendus Biologies, a publication of the French Academy of Sciences.

"Finding stem cells capable of restoring function to different damaged organs would be the Holy Grail of tissue engineering," says lead author David Trisler, PhD, assistant professor of neurology at the University of Maryland School of Medicine.

He adds, "This research takes us another step in that process by identifying the potential of these adult bone marrow cells, or a subset of them known as CD34+ bone marrow cells, to be 'multipotent,' meaning they could transform and function as the normal cells in several different organs."

University of Maryland researchers previously developed a special culturing system to collect a select sample of these adult stem cells in bone marrow, which normally makes red and white blood cells and immune cells. In this project, the team followed a widely recognized study model, used to prove the multipotency of embryonic stem cells, to prove that these bone marrow stem cells could make more than just blood cells. The investigators also found that the CD34+ cells had a limited lifespan and did not produce teratomas, tumors that sometimes form with the use of embryonic stem cells and adult stem cells cultivated from other methods that require some genetic manipulation.

"When taken at an early stage, we found that the CD34+ cells exhibited similar multipotent capabilities as embryonic stem cells, which have been shown to be the most flexible and versatile. Because these CD34+ cells already exist in normal bone marrow, they offer a vast source for potential cell replacement therapy, particularly because they come from a person's own body, eliminating the need to suppress the immune system, which is sometimes required when using adults stem cells derived from other sources," explains Paul Fishman, MD, PhD, professor of neurology at the University of Maryland School of Medicine.

The researchers say that proving the potential of these adult bone marrow stem cells opens new possibilities for scientific exploration, but that more research will be needed to see how this science can be translated to humans.

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Adult stem cells from bone marrow: Cell replacement/tissue repair potential in adult bone marrow stem cells in animal ...

Some worry that a ruling giving donors the ability to sell their bone-marrow tissue will encourage legal sale of other body parts.

STORY HIGHLIGHTS

(Time.com) -- How much would it take for you to consider selling your bone marrow? A U.S. appeals court puts the price at about $3,000 in a ruling that now makes it legal to pay donors for their bone-marrow tissue.

The court's decision may well help thousands of sick patients who need bone-marrow transplants to survive, but it also begs the question, What other body parts might next be up for sale?

The ruling came about at the end of 2011, in a decision to an October 2009 lawsuit brought by a group of cancer patients, parents and bone-marrow-donation advocates against the government over the federal law banning the buying and selling of bodily organs. The plaintiffs were led by Doreen Flynn, who has three daughters who suffer from Fanconi anemia, a blood disorder that requires bone-marrow transplants to treat.

Flynn and the other plaintiffs said that too many such patients die waiting for transplants and argued that we should be allowed to pay people to donate their marrow as a way of ensuring a more reliable supply. The U.S. Court of Appeals for the Ninth Circuit agreed.

Time.com: Facebook now lets organ donors tell their friends

At the core of the plaintiffs' argument was the National Organ Transplantation Act (NOTA), which since 1984 has forbid the buying and selling of human organs, including bone marrow. But new developments in bone-marrow extraction have made marrow donation not much different from donating blood.

Traditionally, bone-marrow donation required anesthesia and long needles to extract the marrow from the hip bones of donors. Now, a technique called peripheral apheresis allows doctors to extract blood stem cells directly from the blood, instead of the bone -- patients first take a drug that pulls stem cells from the bone and into the blood -- meaning that the marrow cells should be considered a fluid like blood, rather than an organ, the plaintiffs argued. NOTA doesn't prohibit payments for blood or other fluids, such as plasma or semen.

U.S. Attorney General Eric Holder decided not to ask the Supreme Court to review the appellate court's decision, which would have been the next step in overturning it. That means the ruling stands -- and that people can now be paid up to $3,000 for their marrow, as long as it is collected by apheresis. In a concession to the spirit of NOTA, however, the compensation can't be in cash; it needs to be in the form of a voucher that can be applied to things such as scholarships, education, housing or a donation to a charity.

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Should people be allowed to sell their organs?

FOR IMMEDIATE RELEASE: July 3, 2012

UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE INVESTIGATORS FIND CELL REPLACEMENT/ TISSUE REPAIR POTENTIAL IN ADULT BONE MARROW STEM CELLS IN ANIMAL MODEL

Scientists Looking for Potential Avenue to Grow Cells of Different Organs

Newswise Baltimore, MD July 3, 2012. Researchers from the University of Maryland School of Maryland report promising results from using adult stem cells from bone marrow in mice to help create tissue cells of other organs, such as the heart, brain and pancreas - a scientific step they hope may lead to potential new ways to replace cells lost in diseases such as diabetes, Parkinsons or Alzheimers. The research in collaboration with the University of Paris Descartes is published online in the June 29, 2012 edition of Comptes Rendus Biologies, a publication of the French Academy of Sciences.

Finding stem cells capable of restoring function to different damaged organs would be the Holy Grail of tissue engineering, says lead author David Trisler, PhD, assistant professor of neurology at the University of Maryland School of Medicine.

He adds, This research takes us another step in that process by identifying the potential of these adult bone marrow cells, or a subset of them known as CD34+ bone marrow cells, to be multipotent, meaning they could transform and function as the normal cells in several different organs.

University of Maryland researchers previously developed a special culturing system to collect a select sample of these adult stem cells in bone marrow, which normally makes red and white blood cells and immune cells. In this project, the team followed a widely recognized study model, used to prove the multipotency of embryonic stem cells, to prove that these bone marrow stem cells could make more than just blood cells. The investigators also found that the CD34+ cells had a limited lifespan and did not produce teratomas, tumors that sometimes form with the use of embryonic stem cells and adult stem cells cultivated from other methods that require some genetic manipulation.

When taken at an early stage, we found that the CD34+ cells exhibited similar multipotent capabilities as embryonic stem cells, which have been shown to be the most flexible and versatile. Because these CD34+ cells already exist in normal bone marrow, they offer a vast source for potential cell replacement therapy, particularly because they come from a persons own body, eliminating the need to suppress the immune system, which is sometimes required when using adults stem cells derived from other sources, explains Paul Fishman, MD, PhD, professor of neurology at the University of Maryland School of Medicine.

The researchers say that proving the potential of these adult bone marrow stem cells opens new possibilities for scientific exploration, but that more research will be needed to see how this science can be translated to humans.

The results of this international collaboration show the important role that University of Maryland School of Medicine researchers play in advancing scientific understanding, investigating new avenues for the development of potentially life-changing treatments, says E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine.

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Study Results: Adult Stem Cells From Bone Marrow

Ed Reschke / Getty Images

A color-enhanced photograph of spongy (Cancellous) bone red bone marrow fills the space.

How much would it take for you to consider selling your bone marrow? A U.S. appeals court puts the price at about $3,000 in a ruling that now makes it legal to pay donors for their bone-marrow tissue.

The courts decision may well help thousands of sick patients who need bone-marrow transplants to survive, but it also begs the question, what other body parts might next be up for sale?

The ruling came about at the end of 2011, in a decision to an October 2009 lawsuit brought by a group of cancer patients, parents and bone-marrow donation advocates against the government over the federal law banning the buying and selling of bodily organs. The plaintiffs were led by Doreen Flynn, who has three daughters who suffer from Fanconi anemia, a blood disorder that requires bone-marrow transplants to treat. Flynn and the other plaintiffs said that too many such patients die waiting for transplants and argued that we should be allowed to pay people to donate their marrow as a way of ensuring a more reliable supply. The U.S. Court of Appeals for the Ninth Circuit agreed.

(MORE: Facebook Now Lets Organ Donors Tell Their Friends)

At the core of the plaintiffs argument was the National Organ Transplantation Act (NOTA), which since 1984 has forbid the buying and selling of human organs, including bone marrow. But new developments in bone-marrow extraction have made marrow donation not much different from donating blood: traditionally, bone marrow donation required anesthesia and long needles to extract the marrow from the hipbones of donors. Now, a technique called peripheral apheresis allows doctors to extract blood stem cells directly from the blood, instead of the bone patients first take a drug that pulls stem cells from the bone and into the blood meaning that the marrow cells should be considered a fluid like blood, rather than an organ, the plaintiffs argued. NOTA doesnt prohibit payments for blood or other fluids, such as plasma or semen.

U.S. Attorney General Eric Holder decided not to ask the Supreme Court to review the appellate courts decision, which would have been the next step in overturning it. That means the ruling stands and that people can now be paid up to $3,000 for their marrow, as long as it is collected by apheresis. In a concession to the spirit of NOTA, however, the compensation cant be in cash; it needs to be in the form of a voucher that can be applied to things such as scholarships, education, housing or a donation to a charity.

While the decision applies only to the nine states covered by the Ninth Circuit court, and only to bone marrow obtained through apheresis, it does raise bigger questions about how we will look at organ donation in the future. With about 114,000 people waiting for organs in the U.S. alone on any given day, and only 3,300 donors, the urgent medical need runs up against moral standards of the value human life. Once we start paying for the parts we need, though, how far do we go? We dont allow people to buy and sell human beings, thats slavery, says Dr. Robert Klitzman, director of the bioethics program at Columbia University. Should we allow people to buy and sell human body parts?

(MORE: Where Do (Some) Babies Come From? In Washington, a New Law Bans Anonymous Sperm and Egg Donors)

Read more from the original source:
A Court Allows Payment for Bone Marrow. Should People Be Able to Sell Their Parts?

Ed Reschke / Getty Images

A color-enhanced photograph of spongy (Cancellous) bone red bone marrow fills the space.

How much would it take for you to consider selling your bone marrow? A U.S. appeals court puts the price at about $3,000 in a ruling that now makes it legal to pay donors for their bone-marrow tissue.

The courts decision may well help thousands of sick patients who need bone-marrow transplants to survive, but it also begs the question, what other body parts might next be up for sale?

The ruling came about at the end of 2011, in a decision to an October 2009 lawsuit brought by a group of cancer patients, parents and bone-marrow donation advocates against the government over the federal law banning the buying and selling of bodily organs. The plaintiffs were led by Doreen Flynn, who has three daughters who suffer from Fanconi anemia, a blood disorder that requires bone-marrow transplants to treat. Flynn and the other plaintiffs said that too many such patients die waiting for transplants and argued that we should be allowed to pay people to donate their marrow as a way of ensuring a more reliable supply. The U.S. Court of Appeals for the Ninth Circuit agreed.

(MORE: Facebook Now Lets Organ Donors Tell Their Friends)

At the core of the plaintiffs argument was the National Organ Transplantation Act (NOTA), which since 1984 has forbid the buying and selling of human organs, including bone marrow. But new developments in bone-marrow extraction have made marrow donation not much different from donating blood: traditionally, bone marrow donation required anesthesia and long needles to extract the marrow from the hipbones of donors. Now, a technique called peripheral apheresis allows doctors to extract blood stem cells directly from the blood, instead of the bone patients first take a drug that pulls stem cells from the bone and into the blood meaning that the marrow cells should be considered a fluid like blood, rather than an organ, the plaintiffs argued. NOTA doesnt prohibit payments for blood or other fluids, such as plasma or semen.

U.S. Attorney General Eric Holder decided not to ask the Supreme Court to review the appellate courts decision, which would have been the next step in overturning it. That means the ruling stands and that people can now be paid up to $3,000 for their marrow, as long as it is collected by apheresis. In a concession to the spirit of NOTA, however, the compensation cant be in cash; it needs to be in the form of a voucher that can be applied to things such as scholarships, education, housing or a donation to a charity.

While the decision applies only to the nine states covered by the Ninth Circuit court, and only to bone marrow obtained through apheresis, it does raise bigger questions about how we will look at organ donation in the future. With about 114,000 people waiting for organs in the U.S. alone on any given day, and only 3,300 donors, the urgent medical need runs up against moral standards of the value human life. Once we start paying for the parts we need, though, how far do we go? We dont allow people to buy and sell human beings, thats slavery, says Dr. Robert Klitzman, director of the bioethics program at Columbia University. Should we allow people to buy and sell human body parts?

(MORE: Where Do (Some) Babies Come From? In Washington, a New Law Bans Anonymous Sperm and Egg Donors)

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Paying for Bone Marrow: Should We Be Able to Sell Our Parts?

Public release date: 2-Jul-2012 [ | E-mail | Share ]

Contact: Kim Newman sciencenews@einstein.yu.edu 718-430-3101 Albert Einstein College of Medicine

July 2, 2012 -- (Bronx, NY) -- Researchers at Albert Einstein College of Medicine of Yeshiva University have found that abnormal bone marrow stem cells drive the development of myelodysplastic syndromes (MDS), serious blood diseases that are common among the elderly and that can progress to acute leukemia. The findings could lead to targeted therapies against MDS and prevent MDS-related cancers. The study is published today in the online edition of the journal Blood.

"Researchers have suspected that MDS is a 'stem cell disease,' and now we finally have proof," said co-senior author Amit Verma, M.B.B.S., associate professor of medicine and of developmental and molecular biology at Einstein and attending physician in oncology at Montefiore Einstein Center for Cancer Care. "Equally important, we found that even after MDS standard treatment, abnormal stem cells persist in the bone marrow. So, although the patient may be in remission, those stem cells don't die and the disease will inevitably return. Based on our findings, it's clear that we need to wipe out the abnormal stem cells in order to improve cure rates."

MDS are a diverse group of incurable diseases that affect the bone marrow and lead to low numbers of blood cells. While some forms of MDS are mild and easily managed, some 25 to 30 percent of cases develop into an aggressive disease called acute myeloid leukemia. Each year, about 10,000 to 15,000 people in the U.S. are diagnosed with MDS, according to the National Marrow Donor Program.

Most cases of MDS occur in people over age 60, but the disease can affect people of any age and is more common in men than women. Symptoms vary widely, ranging from anemia to infections, fever and bleeding. Treatment usually involves chemotherapy to destroy abnormal blood cells plus supportive care such as blood transfusions.

In the current study, lead author Britta Will, Ph.D., research associate in the department of cell biology, and her colleagues analyzed bone marrow stem cells and progenitor cells (i.e., cells formed by stem cells) from 16 patients with various types of MDS and 17 healthy controls. The stem and progenitor cells were isolated from bone marrow using novel cell-sorting methods developed in the laboratory of co-senior author Ulrich Steidl, M.D., Ph.D., assistant professor of cell biology and of medicine and the Diane and Arthur B. Belfer Faculty Scholar in Cancer Research at Einstein.

Genome-wide analysis revealed widespread genetic and epigenetic alterations in stem and progenitor cells taken from MDS patients, in comparison to cells taken from healthy controls. The abnormalities were more pronounced in patients with types of MDS likely to prove fatal than in patients with lower-risk types.

"Our study offers new hope that MDS can be more effectively treated, with therapies that specifically target genes that are deregulated in early stem and progenitor cells," said Dr. Steidl. "In addition, our findings could help to detect minimal residual disease in patients in remission, allowing for more individualized treatment strategies that permanently eradicate the disease."

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More here:
Myelodysplastic syndromes (MDS) linked to abnormal stem cells

By Daily Mail Reporter

PUBLISHED: 07:58 EST, 28 June 2012 | UPDATED: 08:44 EST, 28 June 2012

Robin Roberts' older sister has spoken out about being her sole bone marrow donor after learning she was a match.

Sally-Ann, who anchors a morning show in New Orleans, will be essential to her GMA host sister's treatments for myelodysplastic syndrome (MDS), a blood and bone marrow disease.

The mother-of-three, 55, told the New York Post yesterday how she had been so desperate to be a match for her sister, she and her friends made a prayer circle around the test kit.

'We prayed, "please let this be a match,"' she admitted.

Perfect match: Sally-Ann Roberts, pictured with Robin earlier this month, has spoken about how she learned she would be her sister's sole bone marrow donor

She admitted: 'Im the big sister. Im the one whos supposed to be suffering because of age. But thats not the way it is.'

To donate her bone marrow, Sally-Ann explained that she will have five days of injections to boost her blood cell count, before her blood is passed through a machine that will extract the stem cells her sister, 51, so desperately needs.

'The way it is explained to me is that they will first have to knock out her immune system in order for my stem cells to be accepted by her body,' she said.

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'We prayed that I'd be a match': Robin Roberts' sister Sally-Ann on learning she was the sole bone marrow donor

WWL-TVs Sally-Ann Roberts talks about her sisters health battle. Watch Richard Ford on The Colbert Report. TV tweet of the day so far.

TV Linkzilla Daily for 6/27/12 starts now.

When Good Morning America anchor Robin Roberts announced June 11 that shed been diagnosed with a rare form of bone-marrow cancer MDS, or myelodysplastic syndrome -- and would undergo chemotherapy and a bone-marrow transplant, her sister, WWL-TV anchor Sally-Ann Roberts, was cast in a key recovery role.

Sally-Ann Roberts, it turned out, was a perfect match to be a bone-marrow-cell donor for her sister. The New Orleans anchors medical contribution wont come for weeks or perhaps months, but shes already begun efforts to raise awareness of the need for donors.

Her station has launched a Perfect Match Supporting Sally-Ann & Robin page on its website, which now holds several stories on the topic, including a Wednesday (June 27) piece in which WWL staffers sign up to join a bone-marrow registry.

An informational and registration phone-bank, staffed by volunteers from organ- and bone-marrow-donation organizations, will operate from 6-9 p.m. Thursday (June 28), in coordination with the stations morning news block.

In a recent interview, Sally-Ann Roberts said her match is a real blessing, because only 25 percent of people who need a bone-marrow transplant actually find a match among their siblings.

She continued:

The majority of people who need a bone marrow donor have to go outside of their family in order to find one. Sometimes it's like a needle in a haystack, and that's why Robin wants to use this challenge that she's facing right now to try to bring attention to the national narrow donor registry. Millions of people are part of it. If a person -- man woman or child -- is in search of a bone marrow donor they can go to this registry and have a chance to find one. There are many, many people who have used the registry successfully.

The only problem is that minorities are underrepresented in the donor registry. Unlike organ donations, where it really doesn't matter what the ethnic background of an individual is for an organ donation, bone marrow for stem cells has to be aligned with the person's genetic makeup. And that's why if you're African American you will find a match with another African American. Native Americans, the same thing. So that's why every racial group needs to be represented in the marrow-donor registry. That's what were trying to do. Were trying to direct people to BeTheMatch.org. If they do, they'll get a packet in the mail and will be able to do a swab, just the inside of their cheek, and will get a self-addressed stamped envelope. They mail it back with the required information. They may get a phone call, they may never get a phone call. But people who have done so -- I've gone online to listen to some of their stories -- they feel so grateful that they were able to reach out and help another individual in need.

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WWL-TV and Sally-Ann Roberts rally support for bone-marrow donor registry