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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ primary follow up in a 6 month period

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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