Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | December 2007 |
| End Date: | March 2013 |
| Contact: | Randall W Franz, MD |
| Email: | rfranz2@ohiohealth.com |
| Phone: | 614-566-9035 |
Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease
The purpose of this study is to evaluate the efficacy of dual intramuscular and
intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of
patients with moderate to severe peripheral arterial disease in whom amputation was
considered the only viable treatment option.
Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive
intramuscular and intra-arterial stem cell injections will have improved ankle brachial
index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of
major limb amputations.
intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of
patients with moderate to severe peripheral arterial disease in whom amputation was
considered the only viable treatment option.
Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive
intramuscular and intra-arterial stem cell injections will have improved ankle brachial
index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of
major limb amputations.
Inclusion Criteria:
- Patients at least 18 years of age.
- Patients with moderate or severe limb-threatening PAD, defined as ankle brachial
indices (ABI) less than 0.7 or presence of non-healing ischemic ulcers with stenosis
or occlusion of two of the following lower extremity arteries: anterior tibial,
posterior tibial, and peroneal.
- Patients with conditions that preclude recommendation of traditional endovascular or
open bypass treatments.
Exclusion Criteria:
- Patients younger than 18 years of age.
- Patients who are eligible to undergo traditional endovascular or open bypass for the
treatment of PAD.
- Female patients who are or may be pregnant.
- Patients who are prisoners.
- Patients with mental retardation or are unable to consent for participation
independently.
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