Stem Cell Injections for Amputation Complications

(CHAMP Trial)

Overseen By Karen Lynn, Admin Asst

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Indiana University

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, CHF, ACS, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

81 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michael P Murphy, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults aged 40-90 facing lower limb amputation due to severe artery disease. They must be able to have surgery within 30 days and not be on immunosuppressants, HIV positive, or involved in other trials that affect results. Women who can bear children should use birth control during the study.

Inclusion Criteria

Be ≥ 40 and ≤90 years of age

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

You are taking medication to suppress your immune system for conditions like organ transplant, psoriasis, Crohn's disease, or alopecia areata.

HIV positive, or active, untreated HCV as determined by review of medical records

Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-muscular injections of allogeneic Mesenchymal Stromal Cells 7 days before amputation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for treatment-related adverse events and efficacy of MSCs in promoting freedom from gangrene, revision of amputation, and death

24 weeks

Observation

Tissue collection and analysis of proangiogenic hematopoietic cells recruitment and MSC retention in skeletal muscle

6 months

Treatment Details

Interventions

• Allogeneic bone marrow derived mesenchymal stem cells

Trial Overview The trial tests if injecting mesenchymal stem cells into muscles around the amputation site can reduce wound issues and further amputations. Control groups won't receive these cells but will undergo standard procedures related to amputation.

Participant Groups

Group I: Active/Treatment Group Experimental Treatment 1 Intervention

Amputation performed at 7 days post allogeneic bone marrow derived mesenchymal stem cell injections.

Group II: Observation Group 2 Active Control 1 Intervention

Tissue Collection Group: Amputation performed with no MSC administration. Subjects will not be followed after amputation is performed. Tissue collection will occur at time of amputation.

Group III: Control Group 4 Active Control 1 Intervention

Patients undergoing a standard of care surgical procedure under anesthesia. Core needle biopsies will be collected from the anterior tibial muscle at the time of surgical procedure. No study testing, nor follow up visits will occur.

Group IV: Observation Group 3 Active Control 1 Intervention

Patients undergoing lower extremity bypass grafting procedure. Skeletal muscle samples of the sartorius and anterior tibial muscle will be collected for comparison to treatment group. No study testing, nor follow up visits will occur.

Group V: Observation Group 1 Active Control 1 Intervention

Amputation performed with no MSC administration. Subjects will be followed for incidence of infection and wound healing status to week 24 as a comparator to the Active/Treatment group.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+