| Clinical Trials | |
| Title: | Lower Limb Ischemia Study |
| Purpose: | The purpose of this clinical research is to determine if bone marrow cells that are harvested from your bone and then grown in a lab, or expanded, can be used as a method for treatment of critical limb ischemia in patients with peripheral artery disease. |
| Study Number: | 200055 |
| Number of Patients: | 120 |
| Elgibility: |
If you have a diagnosis of severe peripheral arterial disease (critical limb ischemia) you may have the following symptoms: Severe burning or pain in the toes and/or feet when resting Skin sores (ulcers) on the feet or legs that heal slowly or not at all, or Poor healing response to possible infections, which can lead to tissue death (gangrene) You may qualify for this study if you:· Are between ages 18 to 81 · Do not require kidney dialysis· Are not currently being treated for cancer; and Have no surgeries planned |
| Treatment: | One group of patients will be treated with an experimental tissue product that is produced from a small amount of their own bone marrow. The bone marrow from the hip and injected into the leg that is affected with critical limb ischemia. The other group (the control group) will undergo a mock bone marrow collection and be treated with an electrolyte solution (isotonic salt solution) injected into their affected leg. If you are part of the control group (the group receiving the isotonic salt solution), you will not receive the experimental tissue product. |
| Principal Investigator: | Patrick Stiff, M.D. |
| Enrollment Phone: | (708) 216-2026 |