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UH Case Medical Center launches novel clinical trial using stem cells to prevent amputation
Date:6/18/2013

who undergo below-knee amputation will fail rehabilitation and require chronic institutional care or professional assistance at home.

The trial sponsor, Biomet Biologics (Warsaw, IN), recently completed a Phase I study of 30 subjects to evaluate the safety of autologous concentrated bone marrow aspirate for critical limb ischemia. The results of this study were used to advance the company's MarrowStim concentration technology into the FDA-approved, pivotal IDE trial described here. Overall, the trial will enroll 152 subjects at up to 20 investigational sites.

"This trial offers an opportunity to save a patient's leg when there are no remaining options to improve blood supply," said Dr. Kashyap. "We are pleased to add this capability at UH and provide hope for patients facing the risk of limb loss."

Subjects will be randomized to receive either the investigational treatment involving the MarrowStim P.A.D. Kit (75% chance), or a placebo control involving a sham procedure (25% chance). The trial's primary end point of time to treatment failure, defined as major amputation or death, will be evaluated over a one‐year follow‐up period. Secondary end points, including rest pain, perfusion measurements, quality of life, and safety, will also be evaluated for one year.


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Contact: Mike Ferrari
mike.ferrari@uhhospitals.org
216-844-7239
University Hospitals Case Medical Center
Source:Eurekalert

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