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Home/Biologics/Stem Cells Treat Critical Limb Ischemia
Biologics

Stem Cells Treat Critical Limb Ischemia

August 13, 2012 1 min read Premium comments

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Stem Cells Treat Critical Limb Ischemia
Occluded artery in peripheral vascular disease. Source: Wikimedia Commons and Patho
Secondary

Medistem, Inc., of San Diego, California, and the Chinese Conglomerate Shanghai Jia Fu Medical Apparatus, Inc. have successfully used Medistem’s universal donor stem cell product in two patients with critical limb ischemia. The stem cell product, called Medistem’s Endometrial Regenerative Cell (ERC), is derived from the endometrium—the lining of the uterus. The two patients who were treated, reportedly without any adverse effects, are part of a 15 patient study.

Thomas Ichim, CEO of Medistem, explained in the July 13 news release, “The ERC is unique amongst clinical grade stem cells in that the cell is derived from the endometrium. Every month new blood vessels are formed in the endometrium which subsequently are sloughed off during menstruation. We believe the ERC plays a critical role in forming new blood vessels. Since the biological role of the ERC is to produce new blood vessels, it is our desire to use these cells to produce new blood vessels in the legs of patients with critical limb ischemia.”

Critical limb ischemia is an advanced form of peripheral artery disease that causes approximately 150-200, 000 amputations per year in the USA, according to Dr. Michael Murphy of Indiana University, who is the principle investigator for Medistem’s FDA cleared clinical study on critical limb ischemia.

“Due to the high incidence of diabetes in the Chinese population, critical limb ischemia is a significant cause of suffering in our country, ” said Wei Zhang, CEO of Shanghai Jia Fu Medical Apparatus Inc. “We are optimistic that the lessons we have learned from successfully commercializing DC-CIK can be applied to the first universal donor stem cell that is extracted from the endometrium.” Medistem and Shanghai Jia Fu intend to develop the ERC product in China through a series of clinical trials with the goal of eventually obtaining marketing approval.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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