Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)
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)
Peripheral Vascular Disease (PVD)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Time to treatment failure or death [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: Yes ]Treatment failure is defined as major amputation
- Perfusion and Quality of Life measurements [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: Yes ]
- Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)
- Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)
- Perfusion rate in treated tissue by skin perfusion pressure (SPP)
- Pain intensity using Visual Analogue Scale (VAS)
- Quality of Life (QoL) by questionnaire
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Bone Marrow Cell Concentrate
Bone Marrow Cell Concentrate Prepared Using the Magellan System
Autologous Bone Marrow Cell Concentrate Prepared Using the Magellan System to be injected into the ischemic muscle tissue at 0.5 cc/injection for a total of 12-20 cc.
Other Name: autologous cell concentrate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386216
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Michael Go, MD||Ohio State University|