Stem Cell Authority

A recent study reported in the Journal of the American College of Cardiology described the results of a phase 1 study using stem cells in  reperfused myocardial infarction patients.

The study was a double-blind, randomized, placebo controlled design with one of the groups receiving allogenic human mesenchymal stem cells delivered intravenously and the other placebo. Since the study was a phase 1 study, the primary objective was to demonstrate safety in the group receiving the mesenchymal stem cells.

The actual primary end point was incidence of treatment-emergent adverse events within 6 months.  Two other measures - ejection fraction and left ventricular volumes determined by echocardiography and magnetic resonance imaging, were exploratory efficacy end points.

Results of the study showed that intravenous allogenic human mesenchymal stem cells are safe in patients after acute myocardial infarction . Results also suggested efficacy but this will need to be determined in further studies.

The authors used a mesenchymal stem cell therapy called Prochymal that is marketed by Osiris Therapeutics.  The drug, which consists of stem cells from donor bone marrow, was injected intravenously.

The lead author of the study was Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine.  According to Dr. Hare:

“We’re looking on the time frame here of five years, in the best-case scenario, to have approved cardiac stem cell therapies.”

The trial has now entered into phase 2 which involves 50 hospitals in the United States.

A preliminary study has suggested that stem cells from the fat tissue of patients with Multiple Sclerosis may help mitigate the disease.

The small study, which included only 3 patients, involved the use of what are called Stromal Vascular Fraction cells( SVF) from fat tissue.

All 3 patients reportedly had dramatic improvements in their condition after receiving the SVF cells.

It appears that SVF cells may help by limiting the body’s immune reaction which, in MS, attacks the individual’s own myelin sheath which protects nerve cells. In addition, SVF cells may help promote the growth of new myelin.

Further research will be needed to further elucidate the role of these cells.

Novocell, a small, privately held San Diego company,  recently announced that it has received a patent which would cover all endoderm cells made from human embryonic stem cells.

Last year, Novocell became the first company to announce that it could make insulin producing cells from human embryonic stem cells.

The process involved converting the stem cells into what are called endoderm cells and then into the insulin producing cells.

Endoderm cells are precursor cells that can eventually turn into into cells of what are called endodermal organs such as the pancreas, lungs, intestine, liver, thymus, bladder and thyroid.

The company hopes to explore a cure for diabetes since insulin producing cells are what is missing in diabetes.

Based on the strength of the patent, Novocell hopes to attract financing from a large pharmaceutical company interested in pursuing a diabetes treatment.

There may soon be a new treatment for macular degeneration, a debilitating eye disease that affects 25-30 million people worldwide and causes blindness.

British researchers at the Institute of Ophthalmology at University College London and Moorfields eye hospital, used embryonic stem cells to replace degenerated retinal cells in pigs and rats.

The treatment is so promising that Pfizer, the giant pharmaceutical company, is promising financial backing to expedite the research.

Researchers are hoping to be able to begin a clinical trial in humans in 2 years which would make it the second clinical trial worldwide using stem cells.

Researchers hope that the new treatment could be on the market in six years. The treatment is being envisioned  as a relatively quick outpatient treatment.

The US market for stem cells usage in the orthopedic market is expected to grow to an estimated $200+ million by 2014 according to a report by iData Research.

Adult stem cells have been commercially available for orthopedic usage since 2005 and have been used mainly in spinal fusion surgery. Estimates are that more than 29,000 patients have benefited from the use of adult stem cells.

Prospects for the future include the use of stem cells in traumatic fractures and degenerative joint disease where the hope is that stem cells can help regenerate joint cartilage that is worn down or torn.

As the population ages, the potential use for stem cells for these applications should increase as it has been estimated that over 60% of the population over 65 years of age suffers from osteoarthritis.

In fact, analysts have estimated a growth rate of 33% annually for this market.

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The results of a phase 2 trial released at the recent American College of Cardiology meeting demonstrate that injecting patient’s own stem cells into their heart muscle appears to reduce pain and improve their ability to exercise.

The phase 2 study included 167 adult patients who suffered from severe angina. In addition, these patients were not suitable for revascularization procedures such as coronary artery bypass, stenting, or angioplasty and these patients were already on maximum medical therapy.

All the patients were given a drug to stimulate a type of stem cell from the bone marrow called cd34+ adult stem cells. In all the patients the stem cels were collected and separated out.

In half of the patients , the stem cells were injected into 10 locations in the heart muscle itself. The other half of the patients received saline injections.

The patients were assessed after 6 months. The patients who had received the stem cell injections were able to walk longer on a treadmill, had fewer episodes of chest pain , and had quicker recovery when angina pain did appear.

The researchers intend to test the treatment on larger groups of patients.

British women will now have the opportunity to have their breasts enlarged by the use of stem cells from fatty tissue in their stomachs or thighs.

The technique, which was pioneered for the use of reconstructive breast surgery following breast cancer surgery, is to be made available to a small number of British women in  a clinical trial.

The technique appears to be able to increase breasts by up to 1 cup size but doesn’t restore firmness or uplift.

Fat has been used before for breast reconstruction but the use of stem cells should lead to an increase in blood vessels and a better result.

The technique has been used in Japan for 6 years for both reconstructive and elective enhancement surgery.

Like many stem cell applications, this one has proponents and opponents with the opponenets arguing that the technique should not be used for cosmetic reasons until large clinical trials have been conducted to verify safety.

A major research project has just been announced in the United Kingdom.

The project will attempt to create artificial blood from human embryos and will ultimately test the blood in human patients.

 The project will test embryos left over from in-vitro fertilization labs looking for those embryos which are destined to become O-negative blood.

O-negative blood is considered the universal donor type of blood as it can be transfused into any patient. However only approximately 7% of patients are O-negative.

The advantages of blood developed from embryos are theoretically numerous. The blood would be free of diseases such as HIV and would be available in large quantities which could help mitigate against the blood shortages that health systems currently face.

The project is a collaboration between The National Health Service Blood and Transplant, the Scottish National Blod Transfusion Service, and the Welcome Trust, the world’s largest medical research charity.

Researchers believe that the fact that red blood cells have no nucleus makes them promising as a synthetic product since they cannot develop into cancerous cells. The team hopes to have what is called proof of principle within 3 years.

An Amercian company called Advanced Cell Technology has done some work in this field but was stymied in part by the US ban on stem cell research which was recently rescinded by President Obama. 

The scientists at Advanced Cell Technology demonstrated that it was possible to make up to 100 billion red blood cells but this is still below the 5 trillion red blood cells that are present in a liter of donated blood.

March 16, 2009

DaVinci Biosciences, a privately held company based in Costa Mesa, California announced today the publication of the results of a study involving the use of stem cells in patients with spinal cord injury.

The study, done in Ecuador with the collaboration of Luis Vernaza Hospital, was published in Cell Transplantation, a peer reviewed journal in the regenerative medicine field.

In the study, 8 patients with spinal cord injury, 4 with acute spinal cord injury and 4 with chronic spinal cord injury, were treated with autologous  bone marrow derived stem cells.

The patients received the stem cells via multiple routes and were followed for 2 years. The company announced that the sequential MRI’s showed noticeable morphological changes.

The patients exhibited no worsening and no tumor formation. The patients demonstrated varying degress of improvement in such parameters as bladder control, sensation, and mobility.

The company has produced a video of some of the patients talking about their experiences:

http://bit.ly/DavinciStemCellstudy

President Obama’s executive order March 9, 2009 removed the restrictions that have been in place since 2001 on the use of federal funds for stem cell research.

Since 2001, federal funds have only been eligible for the 21 stem cell lines that were available at that time.

On the campaign trail, Obama had promised that if he were to be elected he would remove the restrictions put in place by President Bush and allow federal funds to be spent on hundreds of newer stem cell lines.

Critics of the Obama executive order point out that in recent years , stem cell scientists have made tremendous progress in creating what are called IPS cells or induced pluripotent cells from adult cells. These IPS cells can be made to act like embryonic stem cells.

Advocates of the executive order however point out that many issues remain before these IPS cells would be able to be used for patients.

Current law prohibits federal funding for the derivation of stem cell lines from embryos frozen in fertility labs in addition to prohibiting the creating of human embryos for the sole purpose of destroying them for stem cells.

Here is a brief review of the history of legislation concerning stem cells in the United States.

In 1999, the Department of Health And Human Services exempted embryonic stem cell research from a 1995 congressional ban for federal financing involving research in which human embryos were destroyed.

Subsequently, the NIH set up guidelines for federal financing in August 2000.

Following his election, George Bush put in place in August 2001, a policy that stated that federal funding would be limited to stem cell lines that were already existent and that funding would not be available for research that involved the destruction of human embryos.