Critical Limb Ischemia (CLI) Clinical Trial
Official title:
Phase I, Non-Randomized, Feasibility Study for the Use of Bone Marrow Cell Concentrate Prepared Using the Magellan System for the Treatment of Critical Limb Ischemia
The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).
Critical limb ischemia (CLI) continues to be an important cause of atherosclerotic morbidity
and mortality despite conventional therapies. Modulation of angiogenesis is a promising
alternative to surgical revascularization. Trials of isolated angiogenic growth factor
therapies using recombinant proteins or gene transfer have been conducted, but with
disappointing results because it is unlikely that a single angiogenic factor is solely or
even primarily responsible for angiogenesis. Emerging stem cell therapies represent a new
approach to the modulation of angiogenesis. Pluripotent hematopoietic stem cells (HSC) hold
promise because they can reproduce a pro-angiogenic milieu in the ischemic limb rather than
upregulate a single angiogenic factor.
For this CLI study, the Magellan® System is utilized for the preparation of autologous cell
concentrate at the point of care. The bone marrow aspirate is obtained from the patient and
concentrated with the cell concentration kit, and delivered intramuscularly to the affected
limb for the treatment of impaired ischemic tissue in order to improve perfusion, reduce
pain and revascularize tissues in patients who have inadequate tissue blood flow,
prohibitive medical comorbidities, or failed previous treatments for revascularization for
the prevention of amputation.
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|---|---|---|---|
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