A study led by a Great Ormond Street doctor has shown that amniotic fluid stem cells can reverse intestinal damage in rats caused by necrotising enterocolitis -- an often fatal disorder that afflicts premature babies.

Expert in regenerative medicine Paolo De Coppi had already proved that amniotic fluid could be reprogrammed in a similar way to how we reprogram embryonic stem cells, and without introducing potentially damaging genes to instigate the transformation (how adult cells are made pluripotent). Though not quite as versatile as the embryonic version, De Coppi showed that they could be converted into liver, bone and nerve cells.

What's interesting about this latest study is that the stem cells calmed the intestinal inflammation, healed and reversed damage done to the gut far better than bone marrow stem cells (used in a rate control group), and in an unexpected way. After being injected, the cells travelled to the tiny villi that line the intestinal walls and absorb nutrients, where it then released an unknown substance that triggered progenitor cells to calm the inflammation and instigate tissue and villi regrowth. The team is unsure exactly how it released a growth factor to kick the progenitor cells into action, but it's hoping further studies could clear this up -- that knowledge could then be used to develop drugs that replicate the same action.

In the meantime, De Coppi says, "we hope that stem cells found in amniotic fluid will be used more widely in therapies and in research, particularly for the treatment of congenital malformations".

Necrotising enterocolitis is common in premature babies, with inflammation rapidly leading to tissue death and a perforated intestine if antibiotics have no effect. At that point, an operation is the only option and these have a 70 percent survival rate due to related risks of surgery at such a young age, and can leave infants with a shortened intestine and trouble eating for the rest of their lives. This latest study gives hope for an injectable, non-invasive solution.

Stem cells have already been shown to have some incredible properties for regenerative medicine -- most recently baboon embryonic stem cells were used to repair damaged arteries. However, due the ethical grey area embryonic experiments reside in, progress has inevitably been slower, with the first official human trials only recently beginning to take place. Stem cells derived from amniotic fluid have huge potential, but would mainly still rely on donors given the impracticalities of storing fluid from every birth. Nevertheless, according to estimates published in a 2005 study, just 150 donors would provide a match for 38 percent of the population.

De Coppi, who in 2010 made headlines when he built an 11-year-old boy a trachea replacement from his own bone marrow stem cells, is currently raising funding for his research into building rejection-free transplants from stem cells.

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Amniotic stem cells heal intestinal disorder that afflicts premature babies

Lawrence LeBlond for redOrbit.com Your Universe Online

Researchers studying stem cells removed from amniotic fluid have found a possible role the cells have on healing damage caused by necrotizing enterocolitis (NEC), a severe inflammation that can destroy tissues in the gut and lead to major organ failure.

The findings, published in the journal Gut, are based on early animal tests that reveal healing and an increase in survival. The researchers say the evidence could lead to a new form of cell therapy for premature babies, but cautioned that more research is needed first.

The study was funded by Great Ormond Street Hospital (GOSH) Childrens Charity and led by University College Londons (UCL) Institute of Child Health (ICH). The researchers investigated how the stem cells work in relation to NEC, which is the most common gastrointestinal surgical emergency in newborns, with mortality rates or around 15 to 30 percent in the UK.

While breast milk and probiotics are known to offer some level of protection against NEC, there are currently no medical treatments available other than emergency surgery. Surgical removal, however, shortens the bowel and can lead to intestinal failure, with some babies needing ongoing intravenous nutrition or intestinal transplant.

Babies born prematurely often have guts that are ill-prepared to handle food, and about one in 10 preemies in neonatal intensive care go on to develop NEC. The inflammation can cause tissue death and lead to holes in the intestine which can lead to even more serious infections.

It is quite a problem and we think it is on the increase, said Dr. Simon Eaton, from UCLs Institute of Child Health.

Dr. Eaton, who was part of the research team investigating the role of amniotic stem cells in laboratory rats programmed to develop fatal NEC, said the injections of the stem cells appeared to increase the survival times of the rats.

Were able to prolong survival by quite a long way, he told the BBC. What appears to be happening is a direct effect on calming inflammation and also stimulating resident stem cells in the gut to be more efficient at repairing the intestines.

The researchers harvested amniotic fluid stem (AFS) cells from rodent amniotic fluid and injected them into rats with NEC. Other rats with the same condition were given bone marrow stem cells taken from their femurs, or were kept on normal nutrition with no treatment, to compare clinical outcomes.

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Stem Cells Heal Damaged Intestinal Tissue In Premature Babies

BACKGROUND: Maxillofacial bone grafting and bone harvesting developed to the scientific level during WWI. The development of radical surgery to treat oral cancers began close to 1906. That effort along with the increase in war-related maxillofacial defects began in 1914. The U.S. Army Medical Corps and the U.S. Army Dental Corps began with a block graft harvest from the lacteral tibia with a reported success rate of 64.5%. During 1918 and 1941, anesthesia became more reliable. The practice of bone harvesting, mostly from the ribs and iliac crest, was utilized in WWII related jaw reconstructions. During WWII one-piece iliac block grafts were used 81% of the time, ribs 15%, onepiece tibia grafts 2%, and chip grafts 1%. In 1944, iliac cancellous bone chips were introduced. After WWII, tumor and civilian trauma were the main indications for mandibular reconstruction and cancellous marrow grafts were the most common. This type of grafting has been popularized in the 1990s and early 2000. Now, free microvascular transfers of the fibula are often used today by nondental surgeons to reconstruct defects of the mandible. Recombinant human bone morphogenetic protein (rhBMP) has shown significant bone regeneration capabilities in maxillofacial and oral bone defects. (Source: Marx, Robert E., Atlas of Oral and Extraoral Bone Harvesting)

HARVESTED BONE: When a bone graft is harvested, there is a period of time before it is placed into the recipient site. It is recommended to minimize the out of body time, but sometimes it can extend up to two hours. The principle of autogenous bone harvesting is to transplant viable osteocompetent cells along with a matrix that contains a signal for bone regeneration. It is necessary to maintain the viability of the grafts. Studies have shown that room-temperature saline preserves more than 95% of graft cell viability for at least four hours. Because autogenous osteocompetent cells and bone marrow stem cells are hardy, they will survive to regenerate bone in most cases unless they are destroyed during the time between harvest and placement. The most common cause of cell viability is contact with sterile distilled water. (Source: Marx, Robert E., Atlas of Oral and Extraoral Bone Harvesting)

NEW TECHNOLOGY: Recombinant human bone morphogenetic protein-2/acellular collagen sponge was FDA approved for orthopedic lumbar spinal fusions, open tibial fractures, oral and maxillofacial sinus floor augmentations and alveolar ridge preservations. It is an alternative to autogenous bone grafting without the morbidity of bone harvesting. It regenerates new bone on its own. The bound BMP in the acellular collagen sponge is chemotactic to stem cells and preosteoblasts. These cells will migrate into the sponge and undergo proliferation and differentiation into osteoblasts, which will then synthesize osteoid. Once this process is complete, the osteoid will undergo the standard remodeling cycle of bone to a mature ossicle in six months. The production of rhBMP-2 begins with restricted enzymes, which is the BMP-2 gene from chromosome 20 in the human genome. This gene is transferred into a bacterial plasmid. Then it is transfected into a chromosome in Chinese hamster ovary cells (CHO) and cultured to increase the numbers. The CHO cells will produce hamster proteins, but also one unique human protein called BMP-2. It is separated to produce a purely human protein free of bacteria or animal proteins and in high concentrations to regenerate bone in humans. (Source: Marx, Robert E., Atlas of Oral and Extraoral Bone Harvesting)

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Mending Mouths: Rebuilding Jawbones With Stem Cells

SAN DIEGO, CA--(Marketwire - Mar 22, 2013) - Medistem Inc. ( PINKSHEETS : MEDS ) announced today it published an update on its RECOVER-ERC congestive heart failure Phase II clinical trial in a peer-reviewed journal (link to paper http://www.translational-medicine.com/content/pdf/1479-5876-11-56.pdf). The publication reports safety of its proprietary stem cell population, termed "Endometrial Regenerative Cells" (ERC), as well as data supporting the patent-pending 30 minute catheter-based retrograde delivery technique through which the stem cells are administered.

"To date, all stem cell trials in the cardiac space use bone marrow and adipose tissue sources.Unlike the painful and highly invasive process of collecting bone marrow and adipose stem cells, our collection processes involves extraction of a small amount of menstrual blood from young healthy donors.In our FDA-cleared manufacturing protocol, one donor generates 20,000 doses," said Alan Lewis, Ph.D., Chief Executive Officer of Medistem. "ERC are administered without tissue matching or the requirement for immune suppressive drugs. Our product is delivered to the point-of-care as a cryogenically preserved allogeneic therapy that is ready to use, without need for end user manipulation.This feature could make it practical for clinicians to efficiently deliver stem cell therapy to large numbers of heart failure patients."

"This is the first time that the minimally-invasive catheter-based retrograde delivery technique has been used in the context of a 'universal donor' stem cell," said Amit N. Patel, M.D., Director of Cardiovascular Regenerative Medicine at the University of Utah and the senior author of this publication."The delivery technique used in the current study can be widely performed by any licensed interventional cardiologist with minimal training.This is in contrast to other stem cell delivery techniques that require extensive user training and complex equipment that is not readily available."

The RECOVER-ERC trial is a 60 patient, double-blind, placebo controlled study in which patients with congestive heart failure are divided into 3 groups, which receive ERC in a dose escalating manner of 50, 100,and 200 million cells.Main efficacy endpoints are at 6 months after treatment with safety endpoints assessed up to one year.

To date, 17 patients have been treated with no treatment associated adverse events reported.The Principle Investigator is Leo Bockeria, M.D., Chairman of the Bakoulev Center and Academician of the Russian Academy of Science.The Bakoulev Center is Russia's premier institute for cardiovascular surgery and cardiology. Every year the Backulev Center performs approximately 30,000 procedures including 7,000 open heart surgeries and more than 12,000 angioplasties.

Amit Patel, M.D., is the International Principle Investigator for the trial and was the first physician to administer stem cells into the human heart.

Safety oversight for the trial is performed by the independent Data Safety Monitoring Board (DSMB) which is chaired by Warren Sherman, M.D., Director of Cardiac Cell-Based Endovascular Therapies at Columbia University.

About Medistem

Medistem Inc., is focused on the development of the Endometrial Regenerative Cell (ERC), a universal donor adult stem cell product. ERCs possess specialized abilities to stimulate new blood vessel growth and can differentiate into lung, liver, heart, brain, bone, cartilage, fat and pancreatic tissue. We believe ERC have the potential to treat a range of diseases, including ischemic conditions, cardiovascular disease, certain neurological diseases, autoimmune diseases (such as Type 1 Diabetes), kidney failure, liver failure, pulmonary diseases and a range of orphan disease indications. ERCs have been cleared by the FDA to begin studies in the United States.

Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Medistem Inc. These can be identified by the use of forwardlooking words, such as "believes," "expects," "may," "intends," "anticipates," "plans," "estimates," or any other analogous or similar expressions intended to identify forwardlooking statements. These forwardlooking statements and estimates as to future performance, estimates, and other statements contained herein regarding matters that are not historical facts, are only predictions and actual events or results may differ materially. We cannot assure or guarantee that any future results described in this presentation will be achieved, and actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Originally posted here:
Menstrual Blood Stem Cells Used to Treat Heart Failure Patients