Clinical Trials for Critical Limb ischemia going to begin soon
Dr. Chris Kontos, co-director of the Duke Heart and Vascular Group, will be coordinating the trial that focuses on the stem cell regime developed by Pluristem Thera¬peutics. In lab tests on animals, the use of stem cells not only improved blood flow, but also grew new blood vessels.
Theray is based on an allogenic concept using stem cells derived from Placenta. These cells are one size fit all, they come from material that is thrown away, and outpatients can be injected in a process that takes 30 minutes. They are observed for six hours and then sent home.”
The treatment is intended for victims of “late stage” ischemia who have not responded to other treatments or surgery and face the prospect of amputation. People selected for the trial will already have a condition related to ischemia, such as an ulcer or nerve pain.
Phase I trials focus on safety. If the treatment is found to be safe, Phase II trials would begin. The US Food and Drug Administration granted Pluristem approval for the Phase I trials earlier this year.
In late July, the first patient was injected with the proposed treatment in a clinical trial in Germany being run in parallel with the US tests. As many as 12 patients will be injected, with a mix of smokers, diabetics and obese subjects to be tested in the US.
Details on critical limb ischemia:
http://www.stemcellgf.org/Critical_Limb_Ischemia.aspx
Details on other diseases – Please visit http://stemcellgf.org/Diseases.aspx
Interested in cord blood banking – Please visit http://stemcellgf.org/provider-cord-blood-banking.aspx
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