Trial Information

Summary: FDA Phase I Trial: Treating Peripheral Vascular Disease with Stem Cells

The Stem Cell Mediated Angiogenesis Trial is an FDA approved Phase I clinical trial for patients with severe peripheral vascular disease causing leg or foot pain while at rest. The only site for the Stem Cell Mediated Angiogenesis Trial is Indiana University School of Medicine, in Indianapolis, Indiana. Participants of the Stem Cell Mediated Angiogenesis Trial receive care at University and Methodist Hospitals, part of Clarian Health Partners.

The primary purpose of this Phase I clinical trial is to examine how safe it is to use a patient’s own stem cells to stimulate new blood vessel growth in a leg with rest pain. Whether or not the stem cells stimulate new blood vessel growth will be examined as a secondary purpose of the study. In the operating room using a general anesthetic, bone marrow will be harvested from the patient’s hip bone. After recovering from the general anesthesia the patient will be transferred back to their room. Meanwhile, the bone marrow will be taken to one of the specialized labs in the hospital where it will take approximately 6 hours to remove and process the stem cells. In the afternoon of the same day, the patient will return to the operating room and receive sedation in preparation for the stem cell injections. Using a topical grid and a syringe with a small needle, Dr. Murphy will inject stem cells (40 injection sites) into the calf muscle of the leg with rest pain. The stem cell injection procedure takes approximately 20 minutes and afterward the patient will return to their room where they will stay overnight.

There are no activity restrictions following the stem cell procedure. The duration of the study is 12 weeks and patients will be required to travel to Indianapolis for follow-up after the procedure at Week 4, Week 8, and Week 12.

Patient Inclusion Criteria:

• Unreconstructable vascular disease as determined by a vascular surgeon
• At least 21 years of age
• Have an ABI of less that 0.5 and a TBI of less than 0.4
• Patients must be competent to give consent
• No history of malignancy

• Patients with evidence of proliferative retinopathy on ophthalmologic examination
• Patients with poorly controlled diabetes mellitus (HbA1C > 6.5%) will be excluded from the study
• Patients will renal insufficiency (Creatinine > 1.6) of failure
• Patients with congestive heart failure (Ejection Fraction <30%)
• Infection of the involved extremity manifest by fever, purulence, cellulites, and an elevated white blood count
• Pregnant women or cognitively impaired adults

The primary outcome of this study is to determine the safety of using autologous stem cells to treat vascular disease. Angiography and Magnetic Resonance Arteriograms will be performed during the screening process and after 12 Weeks. ABI and TcP02 measurements will be obtained at screening and Weeks 4, 8, 12. All adverse events will be recorded for one year.
Key Secondary Outcomes: The secondary outcome of the study is to determine the efficacy of using autologous stem cells for the treatment of vascular disease.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.