A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation (NCT02685098) | Clinical Trial Compass
CompletedPhase 1
A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation
United States81 participantsStarted 2017-01-23
Plain-language summary
Patients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complications after surgery and decrease the incidence of revision and further amputation. Cohort Groups 1-4 will serve as controls.
Who can participate
Age range40 Years – 90 Years
SexALL
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Inclusion criteria
✓. Be ≥ 40 and ≤90 years of age.
✓. Patients requiring lower extremity major amputation, as determined by an independent vascular specialist.
✓. 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)
✓. Amputation can safely be performed up to 30 days after screening, as determined by an independent vascular or orthopedic surgeon.
✓. 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
✕. Patients who are pregnant, planning to become pregnant in the next 12 months, or lactating.
✕. CHF hospitalization within the last 1 month prior to enrollment.\*
✕. Acute coronary syndrome in the last 1 month prior to enrollment.\*
✕. HIV positive, or active, untreated HCV as determined by review of medical records.
✕. History of cancer within the last 5 years, except basal cell skin carcinoma
✕. Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted).
✕. Concurrent enrollment in another clinical investigative trial that may alter the outcomes of enrollment in this trial.
What they're measuring
1
Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale.