In terms of our Sector Companies, Aastrom Biosciences, Athersys, Inc., Opexa Therapeutics and Osiris Therapeutics, all are relying on some combination of mesenchymal stem cells and various growth factors as potential stem cell therapies. Osiris is further along in clinical trials and has had its share of problems in demonstrating the efficacy of mesenchymal cells in attempting extremely difficult therapeutic solutions.
Osiris has sponsored a study led by cardiologist Joshua M. Hare, director of the stem cell institute at the University of Miami Miller School of Medicine, with colleagues at nine other medical centers, about which results were released yesterday. "Stem cell-treated patients had ... significant improvements in heart, lung, and global function,” Hare said in a news release. "Echocardiography showed improved heart function, particularly in those patients with large amounts of cardiac damage."
It's not the first time heart attack patients have been treated with stem cells. But previous studies used bone marrow cells extracted from the patient and then injected directly into the heart. The Hare study enrolled 53 heart attack patients treated within 10 days of their first heart attack. None of the patients required bypass. A fourth of the patients got infusions of an inactive placebo; the others got various doses of the Prochymal cells.
"Stem cell-treated patients had ... significant improvements in heart, lung, and global function,” Hare said in a news release. "Echocardiography showed improved heart function, particularly in those patients with large amounts of cardiac damage."
At another point on the mesenchymal spectrum, the use of mesenchymal stem cells (MSCs, or multipotent stem cells that can differentiate into a variety of cell types) has been claimed to be a promising biological therapy that could be used to treat complicated fractures and other disorders in the skeleton. These cells constitute a unique population of adult stem cells that can readily be isolated from various sites in the human body, especially from bone marrow and adipose (fat) tissues. Following isolation, MSCs can be utilized to repair a variety of injured tissues including bone, cartilage, tendon, intervertebral discs and even the heart muscle.
The conventional method of MSC isolation, using prolonged periods of growth in designated incubators, has proved to be laborious, costly and also possibly injurious to the therapeutic quality of the cells. Therefore, an alternative method involving the immediate use of these stem cells was an unmet need in the field of regenerative medicine.
Now, a Hebrew University group has developed a technology called immuno-isolation in which MSCs are sorted out from the other cells residing in a bone marrow sample, using a specific antibody. In the resultant paper it was shown that the immuno-isolated cells could be immediately used to form new bone tissue when implanted in laboratory animals, without having to undergo a prolonged incubator growth period.
A collaboration was established and a clinical-grade protocol for the use of immuno-isolated MSCs was established. Subsequently a clinical trial was initiated at Hadassah aimed at establishing a foundation for the use of immuno-isolated MSCs in orthopedic surgery.
To date seven patients suffering from complicated fractures have been treated successfully with a combination of their own immuno-isolated MSCs and blood products. The entire procedure lasted a few hours and without any need to grow the cells for weeks in a laboratory.
It is anticipated that future development of the current endeavor will extend to treat other injuries in the skeleton, such as degenerated intervertebral discs or torn tendons. The Gazit group believes that further clinical trials will demonstrate that the immuno-isolation technology is useful in overcoming morbidity in patients suffering from skeletal fractures and diseases, and might restore function and quality of life to sick and injured people.
Adapted from the Hebrew University announcement through EurekAlert.
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