Are you at risk of leg amputation from peripheral arterial disease (leg blood vessel disease) also known as PAD?
Available FDA approved Indianapolis clinical trial for patients with severe peripheral arterial disease (PAD). Symptoms of PAD are leg cramps while walking or foot pain while at rest.
What? Phase I clinical trial titled Stem Cell Mediated Angiogenesis.
Where? Participants receive care at Indiana University Hospital and Methodist Professional Center, part of Clarian Health Partners Indianapolis, Indiana.
Why? To evaluate safety and effectiveness of using a patient’s own stem cells to stimulate new blood vessel growth in their leg.
How? Under general anesthetic, bone marrow is taken from the patient’s hip bone. Adult stem cells which have been removed from the bone marrow are injected into the patient’s leg calf muscle. The process takes approximately two hours. There are no activity restrictions following the stem cell procedure.
When? This is a 12-week study. Patients are required to travel to Indianapolis for the procedure and for follow-up evaluation on week 4, week 8 and week 12.
Who may participate? Patients must meet the following criteria:
Untreatable vascular disease as determined by a vascular specialist
Foot pain at rest, or cramping leg pain while walking
At least 21 years of age
Have an ankle brachial index (ABI) of less that 0.55 or a toe brachial index (TBI) of less than 0.4
Must be competent to give consent
No history of malignancy with the exception on nonmelanoma skin cancer
Who may not participate? Patients may not participate if they meet the following criteria:
Evidence of active proliferative retinopathy on eye examination
Poorly controlled diabetes mellitus (HbA1C greater than 8.5%)
Congestive heart failure with an ejection fraction less than 30%
Infection in the leg or foot shown by fever, pus, cellulitis and an elevated white blood count
Pregnant woman or cognitively impaired adult
For more information:
Janet Klein, RN, MSN, CCRP, Research Coordinator Stem Cell Mediated Angiogenesis Trial Division of Vascular Surgery Indiana Center for Vascular Biology and Medicine Methodist Hospital 1801 N. Senate Blvd. Indianapolis, IN 46202 Telephone: 317-962-0287 E-mail:
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