Critical Limb Ischemia
Conditions
Keywords
CLI, Critical Limb Ischemia, PAOD, Peripheral Arterial Disease, Stem Cells, Limb amputation, Leg ulcers
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.
Interventions
DEVICEBMAC injection
Injection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System
DEVICEPlacebo injection
Injection of placebo into ischemic tissue of the lower extremity
Sponsors
Harvest Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * History of prior failed revascularization attempts * The Patient's case was reviewed at the treating institution's Multidisciplinary Vascular Conference where the patient's status as a poor candidate for conventional therapies was confirmed. * Age ≥18 years and ability to understand the planned treatment * Subject has read and signed the IRB approved Informed Consent form * Patients for whom the following medication(s) is prescribed must have a one month stable baseline therapy prior to enrollment: Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, and or blood pressure medication. If any of these medications are not prescribed notation of the reason for omission is to be provided. * Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 2.5 mg / dL, INR ≤ 1.6 unless on Coumadin, or PTT \<1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR\<1.6 at the time of randomization/surgery.
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). * Ulceration with exposed bone proximal to the distal metatarsal heads (ie. heel or mid foot) * Active clinical infection or infection being treated by antibiotics within one week of enrollment * Treatment with immunosuppressant drugs (including Prednisone \> 5 mg per day). * Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method. * Underwent a major open cardiovascular surgical procedure (carotid endarterectomy, arterial aneurysm or bypass surgery, or coronary artery bypass surgery) or a myocardial infarction within the 3 months prior to randomization * Underwent a successful or partially successful endovascular intervention for peripheral arterial occlusive disease. (ie. Aorta, iliac, femoral, popliteal, or tibial artery angioplasty, stenting, or atherectomy) within the prior 3 months. * Endovascular coronary intervention (ie. Angioplasty, atherectomy, stenting) within 1 month prior to randomization. * Underwent a failed attempt for endovascular revascularization during the prior 1 month. For the purpose of this
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amputation Free Survival | Six Months | Survival without a major (above the ankle) amputation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change In Rutherford Classification | Six Months | Change in the subjects clinical status as measured by Rutherford Classification |
| Change in Pain | Six Months | Change in Subjects perception of pain as measured on a 100 mm visual analog scale |
Countries
United States
Outcome results
None listed