Pivotal Study of the Safety and Effectiveness of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Disease
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Critical Limb Ischemia
- Sponsor
- Harvest Technologies
- Enrollment
- 97
- Locations
- 34
- Primary Endpoint
- Amputation Free Survival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores, ulcers, gangrene, and even amputation. The purpose of this study is to determine if injections of concentrated bone marrow into damaged tissues will result in improved blood flow. If successful, this treatment could improve blood flow to the lower limb, reduce pain, and reduce the frequency of limb amputations.
Detailed Description
Bone marrow aspirate is collected and processed by centrifugation to remove red blood cells. The resulting concentrate of cells is injected into ischemic tissues of the lower limb. The purpose of this study is to determine if injections of concentrated bone marrow nucleated cells into ischemic tissues will result in vasculogenesis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has Peripheral Arterial Occlusive Disease (PAOD) with clinical Rutherford Category 5 disease, as defined in the reporting standards adopted by the Society of Vascular Surgeons(table 1); Minor Tissue loss-focal gangrene with diffuse pedal ischemia
- •Patient meets at least one of the following diagnostic criteria in the study limb:
- •Ankle artery occlusion pressure absolute ≤60 mmHg or ABI ≤0.6
- •Toe artery occlusive pressure \< 50mm Hg or TBI ≤0.6
- •There is no reasonable open surgical or endovascular revascularization option as determined by the treating vascular specialist. Factors that may contribute to the determination of inoperability may include:
- •Anatomical considerations
- •No outflow targets
- •No appropriate conduit (i.e. vein for bypass)
- •Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
- •High risk medical conditions i.e. Unstable cardiac disease.
Exclusion Criteria
- •Life expectancy \<6 months due to concomitant illnesses
- •History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
- •Terminal renal failure with existing dependence on dialysis or serum creatinine \>2.5 mg/dL
- •Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemocult unless follow-up studies reveal patient to be cancer free.
- •Poorly controlled diabetes mellitus (HgbA1C\>10%)
- •Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5
- •Life-threatening complications of the ischemia necessitating immediate amputation
- •Uncorrected occlusion of the common or external iliac artery on index side
- •Absence of any pulsatile Doppler flow below the ankle.
- •Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6).
Outcomes
Primary Outcomes
Amputation Free Survival
Time Frame: Six Months
Survival without a major (above the ankle) amputation
Secondary Outcomes
- Change In Rutherford Classification(Six Months)
- Change in Pain(Six Months)