You may qualify to participate in this clinical study of an investigational treatment if you suffer from Critical Limb Ischemia and have been told by a physician that you are no longer a candidate for surgical or other interventional treatment.
This study seeks to determine if treatment with adult stem cells, taken from the patient’s own bone marrow, can improve healing and prevent amputation.
To qualify to participate, you must be between 18-80 years old with established CLI (Rutherford Category 4 to 5 per the recommendations of the TASC) with angiographic evidence of significant infra-inguinal arterial occlusive disease with no surgical or interventional options for revascularization and no response to optimal medical care as confirmed by a vascular surgeon and/or physician.
Screening period of approximately 7-14 days, study intervention requires about 24 hrs of hospitalization for bone marrow extraction and administration of ASCT01/placebo. Study follow-up is for 12 months at specified intervals, with assessment of study endpoints at day 90.
For additional information or questions about this study, please use the information below to contact us.
Investigator: Karl R Stark, MD