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Stem Cell Injections for Amputation Complications (CHAMP Trial)

Phase 1
Waitlist Available
Led By Michael P Murphy, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up primary follow up in a 6 month period
Awards & highlights

Summary

This trial will test whether injecting stem cells above and below the point of amputation can prevent ischemic wound complications and further amputations.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of mesenchymal stem cell injections may include pain at injection site, infection risk, immune system reactions, or tissue swelling. However, specific risks will depend on individual patient factors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~primary follow up in a 6 month period
This trial's timeline: 3 weeks for screening, Varies for treatment, and primary follow up in a 6 month period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Flow Cytometry
Recruitment of proangiogenic hematopoietic cells into sites of ischemia will be measured and reported as assessed by the role of MSCs injected in human skeletal muscle at the time of amputation.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Active/Treatment GroupExperimental Treatment1 Intervention
Amputation performed at 7 days post allogeneic bone marrow derived mesenchymal stem cell injections.
Group II: Observation Group 2Active Control1 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 4Active Control1 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 3Active Control1 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 1Active Control1 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.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
997 Previous Clinical Trials
1,095,513 Total Patients Enrolled
Michael P Murphy, MDPrincipal InvestigatorIndiana University
3 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

Allogeneic bone marrow derived mesenchymal stem cells Clinical Trial Eligibility Overview. Trial Name: NCT02685098 — Phase 1
Amputation Research Study Groups: Active/Treatment Group, Observation Group 2, Control Group 4, Observation Group 3, Observation Group 1
Amputation Clinical Trial 2023: Allogeneic bone marrow derived mesenchymal stem cells Highlights & Side Effects. Trial Name: NCT02685098 — Phase 1
Allogeneic bone marrow derived mesenchymal stem cells 2023 Treatment Timeline for Medical Study. Trial Name: NCT02685098 — Phase 1
~10 spots leftby Jul 2025