We are currently enrolling patients in a clinical study of an investigational treatment for patients with PAD and non-healing wounds. If you suffer from Critical Limb Ischemia and have been told you are no longer a candidate for surgical or interventional options for revascularization and no response to optimal medical care as confirmed by a vascular surgeon and/or physician, you may be a candidate for a research study of an investigational 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.
Participants will undergo a screening process to see if they qualify. Qualified subjects will spend 1 day in the hospital during the initial study period and will have an additional 5 outpatient visits over the following year. All study procedures will be provided at no cost.
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.
Once qualified, there is a screening period of approximately 7-14 days, study intervention requires about 24 hours of hospitalization for bone marrow extraction and administration of ASCT01 treatment. Study follow-up is for 12 months at specified intervals, with assessment of study endpoints at day 90.
If you choose to take part in this study, you may or may not receive the investigational stem cell treatment.
This is a open-label phase 2 proof of concept study.
All patients will receive the investigational treatment.
Principal Investigator: Karl R Stark, MD