It has been proven through an FDA-approved clinical trial that treating heart attack patients with adult stem cells is safe and seems to repair damaged heart tissue.  The results of this study, which was conducted by Joshua M. Hare, M.D. and director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, and sponsored by Osiris Therapeutics of Columbia, Maryland, were published in the December 8th issue of the Journal of the American College of Cardiology.

The first phase of the trial intended to prove the safety and efficacy of injecting a formulation of adult mesenchymal stem cells, Prochymal, in patients right after they suffered a heart attack, to diminish the damage to the heart muscle.  The sample consisted of 53 patients who had suffered a heart attack between one to ten days before.  They were randomized to one of three doses of stem cells, each dose compared with placebo.  After six months, researchers analyzed the serious side effects that were related to the treatment and used echocardiography to measure the efficacy.

The study discovered that the patients treated with stem cells presented fewer side effects like cardiac arrhythmias and showed important improvements in their heart, lung, and global functions.  According to Dr. Hare, the echocardiography showed better heart function, especially in patients with lots of cardiac damage.  Up to date, damaged cardiac tissue cannot be repaired through any known scientific method, and close to a million United States’ citizens suffer heart attacks each year.

These results will put to rest some of the discussions in regards to clinical stem cell research for heart disease.  Although many think that it is too soon to test stem cells in patients, this study has proven the value of exact and controlled clinical trials. In doing so, it also establishes the basis for the development of novel cell heart therapies.

Many believe that this trial acts as a key point of reference for the advancement of these types of approaches. There are several advantages to mesenchymal stem cells as cell-based therapy; among these are:

-    Can be taken from donors that are genetically different
-    Are easy to prepare
-    Tend to gather around injured spots

It is certainly exciting to imagine what is ahead.  Each study will provide new information, new teachings, and new possibilities for the use of adult stem cell therapies to treat cardiac patients.

Contact your pharmaceutical consultancy firm for more information on stem cell research and the promising future it presents.

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Researchers from the Hebrew University of Jerusalem have developed a new stem cell technology to aid in the better and faster healing of complicated bone fractures.

This technology, which involves the isolation of stem cells from the bone marrow, has been already used successfully in the treatment of severe fractures in seven patients at the Hadassah University Hospital in Jerusalem.

Up to today, the standard treatment in clinical orthopedics for serious bone loss has encompassed basically two options: amputation or long periods of disability.  Equally, prosthetic implants have proven inefficient in the long term.  When there is too much loss of bone, the fracture may not heal, and this is the case of more than a million people per year, just in the United States.

In the last years, there have been promising advances for biological therapy to treat complicated fractures and skeleton disorders, specifically by using mesenchymal or multipotent stem cells (MSC’s), which can differentiate between various cell types.  These cells are unique adult stem cells that can be rapidly isolated from various places in the body, mainly bone marrow and fat tissues, and used to repair different injured tissues like bone, cartilage, tendons, intervertebral discs, and even heart muscle.

The way in which MSC isolation is normally conducted is lengthy, expensive, and also harmful to the healing quality of the cells, because it requires long periods of growth inside incubators.  It was urgent to find a way that would allow for the immediate use of stem cells; the regenerative medicine field was begging for one, and the Hebrew University heard them.

The technology this group developed is called immuno-isolation.  Basically, MSC’s are sorted out in a bone marrow sample by using a specific antibody.  It was proven that this technique made it possible to immediately use the cells to create new bone tissue in lab animals.  After this discovery, several scientists from different interested parties joined forces to establish a clinical-grade protocol for the use of immuno-isolated MSC’s.

The head of orthopedics at Hadassah University Hospital, the Good Manufacturing Practice facility at Hadassah, and the Gazit group at the Faculty of Dental Medicine, conducted a clinical trial in order to establish the foundation for the use of immuno-isolated MSC’s in orthopedic surgery.

Seven patients have benefited so far from the treatment of combining their own immuno-isolated MSC’s and blood products.  The procedure lasted a few hours and didn’t require the growing of cells in a lab.

This success is expected to touch other skeleton injuries, like degenerated intervertebral disks and torn tendons.  It is expected that this treatment will help tackle morbidity in patients with skeletal fractures and diseases, and will help re-establish function and quality of life for many people.

In hopes of making this technology available to many more, the university has licensed the immuno-isolation technology to TheraCell Inc. in California since July 2009.  This organization will develop and commercialize this technology thoroughly for advanced regenerative medical purposes, like spinal fusion.

The mission of life sciences consulting firms is to help pharmaceutical companies land opportunities like this one, where they are able to change lives for the better, showing care and respect for patients in need, while staying at the head of innovation.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).