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This study examines, at the clinical and tissue level, the use of donor bone marrow-derived mesenchymal stem cells in patients who require lower-limb amputation. Patients aged 40 to 90 for whom an independent vascular specialist has determined that major amputation is needed could take part. It was conducted in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Be ≥ 40 and ≤90 years of age. 2. Patients requiring lower extremity major amputation, as determined by an independent vascular specialist. 3. If ulceration or gangrene present, it is distal to malleoli (to allow adequate length of ATM area of approximately 3cm x 10cm x 3 cm) 4. Amputation can safely be performed up to 30 days after screening, as determined by an independent vascular or orthopedic surgeon. 5. Females of childbearing potential must be willing to use one form of birth control for the duration of the study. Female participants must undergo a blood or urine pregnancy test at screening. Exclusion Criteria: 1. Patients who are pregnant, planning to become pregnant in the next 12 months, or lactating. 2. CHF hospitalization within the last 1 month prior to enrollment.\* 3. Acute coronary syndrome in the last 1 month prior to enrollment.\* 4. HIV positive, or active, untreated HCV as determined by review of medical records. 5. History of cancer within the last 5 years, except basal cell skin carcinoma 6. Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted). 7. Concurrent enrollment in another clinical investigative trial that may alter the outcomes of enrollment in this trial. 8. Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata). 9. Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial. * As defined by the standard definitions of CHF and ACS by the American Heart Association.