Stem cells found to heal damaged artery in lab study in baboons

Jan. 10, 2013 Scientists at the Texas Biomedical Research Institute in San Antonio have for the first time demonstrated that baboon embryonic stem cells can be programmed to completely restore a severely damaged artery. These early results show promise for eventually developing stem cell therapies to restore human tissues or organs damaged by age or disease.

"We first cultured the stem cells in petri dishes under special conditions to make them differentiate into cells that are the precursors of blood vessels, and we saw that we could get them to form tubular and branching structures, similar to blood vessels," said John L. VandeBerg, Ph.D., Texas Biomed's chief scientific officer.

This finding gave VandeBerg and his team the confidence to do complex experiments to find out if these cells could actually heal a damaged artery. Human embryonic stem cells were first isolated and grown in 1998.

The results are presented in a manuscript, co-authored by Texas Biomed's Qiang Shi, Ph.D., and Gerald Shatten, Ph.D., of the University of Pittsburgh, published in the January 10, 2013 issue of the Journal of Cellular and Molecular Medicine.

The scientists found that cells derived from embryonic stem cells could actually repair experimentally damaged baboon arteries and "are promising therapeutic agents for repairing damaged vasculature of people," according to the authors.

Researchers completely removed the cells that line the inside surface from a segment of artery, and then put cells that had been derived from embryonic stem cells inside the artery. They then connected both ends of the arterial segment to plastic tubing inside a device called a bioreactor which is designed to grow cells and tissues. The scientists then pumped fluid through the artery under pressure as if blood were flowing through it.

The outside of the artery was bathed in another fluid to sustain the cells located there. Three days later, the complex structure of the inner surface was beginning to regenerate, and by 14 days, the inside of the artery had been perfectly restored to its complex natural state. It went from a non-functional tube to a complex fully functional artery.

"Just think of what this kind of treatment would mean to a patient who had just suffered a heart attack as a consequence of a damaged coronary artery. And this is the real potential of stem cell regenerative medicine -- that is, a treatment with stem cells that regenerates a damaged or destroyed tissue or organ," VandeBerg said.

To show that the artery couldn't heal itself in the absence of stem cells, the researchers took a control arterial segment that also was stripped of the cells on its interior surface, but did not seed it with stem cells. No healing occurred.

Stains for proteins that indicate functional characteristics showed that the healed artery had completely normal function and could do everything that a normal artery does in a healthy individual.

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Stem cells found to heal damaged artery in lab study in baboons

Mesoblast's NeoFuse Stem Cell Product Shows Positive Results in Phase 2 Lumbar Spinal Fusion Trial

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MELBOURNE, Australia, Jan. 11, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX:MSB) (MBLTY) today announced that its Phase 2 clinical trial for lumbar spinal fusion had successfully met its safety and efficacy endpoints.

The results suggest that Mesoblast's NeoFuse product comprising allogeneic Mesenchymal Precursor Cells (MPCs) is as effective for interbody lumbar fusion as the gold standard, bone autograft, without the need for a second surgical procedure and its attendant morbidity risks. These results support the progression of clinical development of NeoFuse to a Phase 3 trial in interbody lumbar fusion.

The results were highlighted during a presentation to the 31 st annual JP Morgan Healthcare Conference in San Francisco by Mesoblast Chief Executive Professor Silviu Itescu.

Twenty four (24) patients were enrolled and randomized over 5 sites in the United States with 8 patients in each treatment arm -- bone autograft standard of care (Control), 25 million MPCs (25M), and 75 million MPCs (75M). Patients underwent the surgical procedure, one or two level fusions using a posterior approach to the spine, and were evaluated for safety and efficacy. The median follow-up times for the three treatment groups were 23.9, 20.7, and 22.9 months for the bone autograft, 25M, and 75M groups, respectively.

MPCs were well tolerated with no cell-related serious adverse events and no ectopic bone formation at all. Notably, MPC treated groups had 30-43% lower mean estimated blood loss during surgery compared to the autograft treatment group (p less than 0.05 for the 25M group).

At 12 months, fusion was achieved in 85.7% of patients in the 25M treatment group compared to 62.5% in the 75M and 75% in the control patient groups. Overall, patients from all three treatment groups had a clinically significant and comparable decrease in low back and leg pain, assessed on the Visual Analogue Scale and functional improvement, assessed by the Oswestry Disability Index questionnaire.

Dr Randall Dryer, an orthopedic surgeon with the Central Texas Spine Institute and an investigator in Mesoblast's study, said: "For patients whose spinal discs have degenerated too extensively for repair, bony fusion of adjacent vertebra is the primary option to eliminate chronic and debilitating pain.

"Other than autograft, there is no approved product for posterior spinal fusion, a surgical approach which accounts for 62% of all lumbar fusion procedures. There is a critical unmet need for new technologies to achieve fusion that are safe, effective, and that eliminate the need for bone autograft.

"Based upon my experience in the Phase 2 study, Mesoblast's cells may provide a significant and valuable option to achieve fusion in patients with severe spinal disc degeneration and these results warrant progressing to a Phase 3 study," Dr Dryer added.

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Mesoblast's NeoFuse Stem Cell Product Shows Positive Results in Phase 2 Lumbar Spinal Fusion Trial

Stem cell treatment for spine tested

AN Australian-invented stem cell treatment for spinal surgery has been successfully used for the first time in the United States.

The patented stem cells product created by Melbourne-based company Mesoblast was trialled in a small group of patients with spinal discs that had degenerated beyond repair.

The bone marrow-derived stem cells - called mesenchymal precursor cells (MPCs) - were used to promote bone growth to fuse together spinal vertebrae, to eliminate debilitating leg and back pain.

If the procedure ultimately passes the final stage of clinical trials and is approved by America's drug regulator, it would potentially provide patients worldwide with a quicker and less invasive procedure.

The Food and Drug Administration (FDA)-approved trial compared the use of stem cells to fuse vertebrae with bone harvested from the patient's own hip, the current gold standard for this common operation.

The stem cells were used in conjunction with two chemicals to encourage bone growth, said Texas surgeon Dr Randall Dryer, who performed a number of surgical procedures in the trial.

The chemicals, hydroxyapatite and tricalcium phosphate, are non-cellular components of bone that tell the stem cells to turn into bone-forming cells, rather than other tissues, Dr Dryer said.

"If you put these cells into an environment that stimulates them to grow into bone, they do," Dr Dryer told AAP.

"That eliminates us having to take the patient's own bone from a different location to pack in there."

Dr Dryer, an orthopedic surgeon at the Central Texas Institute in Austin, said eight of the 24 patients enrolled in the trial had the surgery using their own bone.

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Stem cell treatment for spine tested

DOH: Stem cell therapy dangerous

By JENNY F. MANONGDO

Manila, Philippines Doctors yesterday warned against fatal complications of the use of stem cell therapy.

According to the Philippine Society for Stem Cell Medicine (PSSCM), a stem cell transplant poses a host of complications, including fatal complications that depend on several factors such as the type of blood disorder, type of transplant and the age and health of the person receiving the transplant. If the stem cell that you received is not from your own body, it could lead to fatal complications, PSSCM said.

The Philippine Medical Association (PMA) also warned that a patients body may reject the transplant stem cells from a donor.

Although some people experience few problems with a transplant, others may develop complications that may require treatment or hospitalization. Some complications could even be life-threatening, said Dr. Leo Olarte, PMA vice-president.

According to Olarte, the complications that can arise with a stem cell transplant include graftversus-host disease, stem cell (graft) failure, organ injury, infections, cataracts, infertility, new cancers, and even death.

According to Olarte, a person who will undergo a stem cell transplant from a donor (allogeneic stem cell transplant) may be at risk of graft-versus-host disease.

This condition occurs when a donors transplanted stem cells attack your body. Graft-versushost disease can be mild or severe. It can occur soon after your transplant or months to years later. Aside from the graft-versushost disease, stem cell transplant from a donor can likewise affect any organ, commonly the skin (rash, often like sunburn), gut (mouth sores, abdominal pain, diarrhea, nausea or vomiting), liver (jaundice or yellowing of the skin), lungs (blocked airways) or eyes (irritation and light sensitivity).

Olarte said it could also lead to chronic disability arising from organ injury or infections that are potentially life-threatening.

Commercial establishments offering stem cell treatments have increased following its popularity in the treatment of various diseases.

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DOH: Stem cell therapy dangerous

Stem cell could lead to complications, death

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Stem cell could lead to complications, death

Doctors Warn Against Fatal Stem Cell Complications

MANILA Philippines --- Doctors yesterday warned against the fatal complications of the use of stem cell therapy.

According to the Philippine Society for Stem Cell Medicine (PSSCM), a stem cell transplant poses a host of complications, including fatal complications that depend on several factors such as the type of blood disorder, type of transplant, and the age and health of the person receiving the transplant.

"If the stem cell that you received is not from your own body, it could lead to fatal complications," PSSCM said.

The Philippine Medical Association (PMA) also warned that a patient's body may reject the transplant stem cells from a donor.

"Although some people experience few problems with a transplant, others may develop complications that may require treatment or hospitalization. Some complications could even be life-threatening," Dr. Leo Olarte, PMA vice president said.

According to Olarte, the complications that can arise from a stem cell transplant include graft-versus-host disease, stem cell (graft) failure, organ injury, infections, cataracts, infertility, new cancers, and even death.

According to Olarte, a person who will undergo a stem cell transplant from a donor (allogeneic stem cell transplant) may be at risk of graft-versus-host disease.

"This condition occurs when a donor's transplanted stem cells attack your body. Graft-versus-host disease can be mild or severe. It can occur soon after your transplant or months to years later. Aside from the graft-versus-host disease, stem cell transplant from a donor can likewise affect any organ, commonly the skin (rash, often like sunburn), gut (mouth sores, abdominal pain, diarrhea, nausea or vomiting), liver (jaundice or yellowing of the skin), lungs (blocked airways) or eyes (irritation and light sensitivity)."

Olarte said it could also lead to chronic disability arising from organ injury or infections that are potentially life-threatening.

Commercial establishments offering stem cell treatments have increased following its popularity in the treatment of various diseases.

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Doctors Warn Against Fatal Stem Cell Complications

Malaya Business News Online – Philippine Business News | Online News Philippines

Details Published on Wednesday, 09 January 2013 23:00 Written by GERARD NAVAL

The Philippine Society for Stem Cell Medicine (PSSCM) yesterday warned the public that stem cell treatment, an emerging medical procedure, poses risks that could be fatal.

Dr. Leo Olarte, PSSCM spokesman, said stem cell treatment has been found to carry a whole range of risky complications with some being fatal.

He said these include graft-versus-host disease (allogeneic transplant only), stem cell (graft) failure, organ injury, infections, cataracts, infertility, new cancers, and death.

In particular, Olarte explained that the graft-versus-host disease can occur soon immediately after the transplant or months to years later.

This condition occurs when a donors transplanted stem cells attack your body, said Olarte.

He said it may arise from factors such as the type of blood disorder, the type of transplant, and the age and health of the person.

Olarte also noted that graft-versus-host disease can affect any organ, but is commonly seen in the skin (rash, often like sunburn), gut (mouth sores, abdominal pain, diarrhea, nausea or vomiting), liver (jaundice or yellowing of the skin), lungs (blocked airways) or eyes (irritation and light sensitivity).

Last October, the Department of Health (DOH) issued an advisory saying stem cell therapy is a procedure that is not yet an adopted standard way of treatment and remains under clinical evaluation.

Stem cell therapy is a type of intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury.

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Malaya Business News Online - Philippine Business News | Online News Philippines

Forward for Stem Cell Funding

The US Supreme Court has declined to review Sherley v. Sebelius US Court of Appeals ruling, ending the legal effort to block federally funded research on human embryonic stem cells, reports ScienceInsider.

National Institutes of Health Director Francis Collins says he was "very pleased" with the decision. "[It] allows the ruling to stand, and enables NIH to continue conducting and funding stem cell research, following the strict ethical guidelines put in place in 2009," he says in a statement. "Patients and their families who look forward to new therapies to replace cells lost by disease or injury, or who may benefit from new drugs identified by screening using stem cells, should be reassured that NIH will continue supporting this promising research."

The suit was brought by James Sherley and Theresa Deishe, both adult stem cell researchers, after the Obama administration issued an executive order in 2009 expanding the human stem cell lines that are eligible for federal funding. Sherley and Deishe argued that NIH violated the Dickey-Wicker amendment that bars it from funding research that destroys embryos, Donald Zuhn at Patent Docs adds.

They received a preliminary injunction in 2010, but that was then vacated by the US Court of Appeals for the District of Columbia Circuit, Zuhn says. The Supreme Court then denied their petition for appeal.

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Forward for Stem Cell Funding

America Stem Cell, Inc. Awarded a Phase I SBIR to Explore the Therapeutic Potential of Its Platform Technology (ASC …

SAN ANTONIO--(BUSINESS WIRE)--

America Stem Cell, Inc. (ASC) today announced that it has been awarded an Advanced Technology Small Business Innovation Research (SBIR) grant from the National Heart Lung and Blood Institute at the National Institutes of Health. This grant will be led by Dr. Leonard Miller, VP Preclinical Research at ASC, in collaboration with Dr. Larry Sherman at the Oregon National Primate Research Center, Oregon Health & Science University (OHSU). Dr. Shermans lab has over 15 years of extensive experience in multiple models of demyelinating diseases such as multiple sclerosis (MS), and in the application of these models to identify novel therapeutic approaches. Furthermore, the first-ever transplants of human NSCs into human patients for Batten Disease, a demyelinating disease that affects children, were at Dr. Shermans Institute (OHSU).

The studies outlined within the presently approved grant will examine the effect of ASCs lead technology, ASC-101, in combination with neural stem cells in an experimental mouse model of MS. MS is an autoimmune disease that affects the central nervous system (brain and spinal cord). MS is caused by damage to the myelin sheaths that cover nerve fibers. Degradation of these sheaths causes signals along the nerve fiber to slow down or even stop. Over 400,000 people in the United States have been diagnosed with MS, and the number worldwide is 2.1 million. Presently there is no cure for MS.

America Stem Cell has demonstrated that ASC-101 enhances the ability of stem cells to migrate to their target tissue. While most companies are concerned with the type of cells used for cell therapy (i.e. the hardware), America Stem Cell addresses how to get the cells to go where they are needed most (i.e. the software). With this award, America Stem Cell will expand the potential for therapeutic application of ASC-101 with neural stem cells. According to Dr. Leonard Miller, the Co-Principal Investigator on the grant, The successful combination of ASC-101 with neural stem cells would allow the treatment of not only MS but also potentially a number of other neurological disorders, such as traumatic brain and spinal cord injuries, stroke, and neurodegenerative diseases like amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).

America Stem Cell, Inc. is a clinical stage company that is in clinical trials at the University of Texas M.D. Anderson Cancer Center for improving clinical outcomes for cancer patients undergoing hematopoietic stem cell transplantation. This award enables America Stem Cell to expand the development of ASC-101 to yet another cell type. Lynnet Koh, CEO of America Stem Cell, noted, The combination of ASC-101 with neural stem cells could synergistically enhance the therapeutic and regenerative capacity of these cells and most importantly provide an off-the-shelf, effective solution for nerve damage due to multiple types of injuries or diseases. ASC-101 is a transformative technology with the potential to improve clinical outcomes for patients undergoing a wide variety of cell therapies for the treatment of diseases such as graft versus host disease, diabetic complications, neurological disorders, and ischemic diseases such as myocardial infarctions, retinopathy and critical limb ischemia. America Stem Cell has established a number of collaborations examining the potential of ASC-101 to improve cell therapies for multiple clinical conditions using a wide variety of cell types.

About America Stem Cell, Inc.

America Stem Cell is a privately held biotechnology company based in San Antonio, TX, with offices in San Diego, CA, and is dedicated to the development and commercialization of enabling technologies to enhance and expand the therapeutic potential of cell therapies. The key technology platforms (ASC-101 and ASC-102) are designed to improve the homing and engraftment of cells to target organs. ASC-101 is currently in clinical trials to improve the therapeutic potential of hematopoietic stem cells for patients in need of hematopoietic stem cell transplantation. Additionally, these technologies have the potential to enhance the efficacy of cell therapies for the treatment of inflammation from chemotherapy/radiation, autoimmune diseases, neurological diseases, and ischemic diseases including myocardial infarction and stroke. America Stem Cell has partnerships and collaborations with Kyowa Hakko Kirin, Spectrum Medical Innvoations, Florida Biologix, and various medical research institutions including the University of Texas M.D. Anderson Cancer Center, Oklahoma Medical Research Foundation, Fred Hutchinson Cancer Center, University of California San Diego, Sanford-Burnham Institute, Indiana University, Juvenile Diabetes Research Foundation, as well as corporate partnerships. For additional information, please contact Lynnet Koh at 760-612-6277, or view http://www.americastemcell.com.

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America Stem Cell, Inc. Awarded a Phase I SBIR to Explore the Therapeutic Potential of Its Platform Technology (ASC ...

Stem cell materials could boost research into key diseases

Jan. 8, 2013 Stem cell manufacturing for drug screening and treatments for diseases such as Huntington's and Parkinson's could be boosted by a new method of generating stem cells, a study suggests.

Scientists have developed a family of compounds that can support the growth of human embryonic stem cells on a large scale for use in drug testing or treatments.

The new materials, which are water-based gels, act as a tiny scaffold to which cells can cling as they grow. Normally cells must be grown on expensive biological surfaces that can carry pathogens and contaminate cells.

Once cells have multiplied sufficiently for their intended purpose, the gels can be cooled, enabling the stem cells to drop off the scaffold without becoming damaged.

The new approach surpasses existing techniques of separating cells by mechanical or chemical means, which carry a greater risk of damage to cells.

Scientists say the materials could offer a means of enabling the stem cells to be produced in large numbers efficiently and without the risk of inadvertent contamination, facilitating research, drug screening programmes and clinical applications that call for large numbers of cells.

Researchers at the University of Edinburgh developed the new materials by screening hundreds of potential compounds for their ability to support stem cell growth. From a shortlist of four, one has been found to be effective, and researchers say the remaining three show similar potential.

Stem cells provide a powerful tool for screening drugs as they can be used to show the effects of drugs on cells and systems within the body.

The study, published in Nature Communications, was supported by the European Union Framework 7 Grant Funding. The gels are being developed under licence by technology company Ilika.

Dr Paul de Sousa, of the University of Edinburgh's Scottish Centre for Regenerative Medicine, said: "This development could greatly enhance automated production of embryonic stem cells, which would improve the efficiency and reduce the cost of stem cell manufacturing. We are also looking into whether this work could help develop pluripotent stem cells induced from adult cells."

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Stem cell materials could boost research into key diseases