A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation (CHAMP)

  • End date
    May 21, 2026
  • participants needed
  • sponsor
    Indiana University
Updated on 21 October 2022
ischemic wound
limb ischemia


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.


This is a phase I single center open label trial study that will enroll twenty-six (26) patients requiring semi-elective lower extremity major amputation within a 30 day period for non-infectious complications related to critical limb ischemia (CLI). After enrollment patients will be scheduled for amputation 7 days after MSC administration. The investigational treatment uses allogeneic bone marrow derived mesenchymal stem cells at the point of care. Allogeneic MSCs will be injected in the gastrocnemius muscle and anterior tibialis muscle of twenty-six (26) patients undergoing major amputation. Through a review of treatment related adverse events over 6 months we will test the hypothesis that allogeneic MSCs do not result in significant cardiovascular, respiratory, or infectious treatment related adverse events. Through an exploratory investigation we will assess the efficacy of MSCs in promoting freedom from gangrene, revision of amputation, and death after major amputation.

Condition Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease, Vascular Disease, Arterial Occlusive Disease, Arteriosclerosis, Atherosclerosis, Cardiovascular Disease, Pathologic Processes, Orthopedic Procedures, Amputation
Treatment Allogeneic bone marrow derived mesenchymal stem cells
Clinical Study IdentifierNCT02685098
SponsorIndiana University
Last Modified on21 October 2022


Yes No Not Sure

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
HIV positive, or active, untreated HCV as determined by review of medical records
Acute coronary syndrome in the last 1 month prior to enrollment
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
Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata)
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
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