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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
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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Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,034 Previous Clinical Trials
1,119,071 Total Patients Enrolled
Michael P Murphy, MDPrincipal InvestigatorIndiana University
3 Previous Clinical Trials
41 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking medication to suppress your immune system for conditions like organ transplant, psoriasis, Crohn's disease, or alopecia areata.You had a heart condition called acute coronary syndrome within the past month before joining the study.You have been diagnosed with congestive heart failure (CHF) or acute coronary syndrome (ACS) according to the guidelines of the American Heart Association.You need to have a specialist determine if you need to have a major amputation on your lower extremity.You had any type of cancer, except for a type called basal cell skin carcinoma, in the past 5 years.If you have sores or tissue death, they must be located below the ankle bones to ensure there is enough space for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Active/Treatment Group
- Group 2: Observation Group 2
- Group 3: Control Group 4
- Group 4: Observation Group 3
- Group 5: Observation Group 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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