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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether stem cell injections can prevent complications after leg amputations caused by poor blood flow (atherosclerotic limb ischemia). Participants will receive injections of specialized cells (allogeneic bone marrow-derived mesenchymal stem cells) in their legs to determine if this reduces issues like wound problems and the need for additional surgeries. The trial includes different groups, with some receiving the treatment and others serving as comparison groups. It is suited for those requiring a lower leg amputation due to circulation problems, as confirmed by a vascular specialist. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant medications, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using donated mesenchymal stem cells (MSCs) in treatments carries some risks. Earlier studies found that the most common side effects include blood clots, which can block blood vessels, and tissue thickening and scarring. However, these findings come from earlier studies.

Since the current trial is in its first phase, researchers are primarily assessing the treatment's safety. The treatment is still under evaluation for safety, and its tolerability is not yet known. Considering these factors can help in making an informed decision about joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using allogeneic bone marrow-derived mesenchymal stem cells (MSCs) for treating complications from amputations because they offer a novel approach that may improve healing and recovery. Unlike traditional treatments, which typically involve wound care and infection management, MSCs have the potential to enhance tissue regeneration and reduce inflammation directly at the cellular level. This is due to their unique ability to transform into various cell types and release growth factors that support tissue repair. The promise of MSCs lies in their potential to accelerate healing and improve outcomes for patients undergoing amputation, making them a groundbreaking alternative to conventional care.

What evidence suggests that this trial's treatment could be effective for amputation complications?

Research has shown that mesenchymal stem cells (MSCs) might offer a promising treatment for issues related to critical limb ischemia (CLI). In this trial, participants in the Active/Treatment Group will receive allogeneic bone marrow-derived MSC injections. Studies have found that MSCs can improve blood flow in damaged areas, which is crucial for healing. They present a possible alternative to surgery for restoring blood flow in people with CLI. Early results suggest that MSCs might lower the risk of gangrene and reduce the need for further amputations. This is because MSCs can repair tissue and promote the growth of new blood vessels, addressing the main issues of poor circulation. ^{3 6 7 8 9}

Who Is on the Research Team?

Michael P Murphy, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02685098

A Clinical and Histological Analysis of Mesenchymal Stem ... Through an exploratory investigation we will assess the efficacy of MSCs in promoting freedom from gangrene, revision of amputation, and death after major ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4429747/

MSCs Isolated From Patients With Ischemic Vascular ... Stem cell therapies using bone marrow–derived mesenchymal stem cells (BM-MSCs) have been explored as a potent alternative treatment for revascularization in CLI ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9449296/

Emerging roles of mesenchymal stem cell therapy in ... Mesenchymal stem cells (MSCs) are currently considered one of the most encouraging cells as a regenerative alternative for the surgical treatment of CLI.

4. jvascsurg.org jvascsurg.org/article/S0741-5214(17)32672-1/pdf

Rationale and design of the Clinical and Histologic Here, we describe the ongoing phase 1/2 Clinical and Histologic Analysis of. Mesenchymal Stromal Cells in AmPutations (CHAMP) trial, which will provide crucial ...

5. mdpi.com mdpi.com/1422-0067/24/24/17512

Cell Therapy of Vascular and Neuropathic Complications ... In this article we propose cell therapy as an alternative strategy for those patients. We also suggest the optimal time-frame for an effective therapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9659480/

Adverse events, side effects and complications in ... Clinical trials reported thromboembolism and fibrosis as the most common adverse events of MSCs therapy.

7. jvascsurg.org jvascsurg.org/article/S0741-5214(21)01739-0/fulltext

Safety and Feasibility of Autologous and Allogeneic Cell ... Ischemic wound complications of below-the-knee amputation (BKA) will necessitate conversion to above-the-knee amputation (AKA) in ≤36% of cases.

8. jvascsurg.org jvascsurg.org/article/S0741-5214(21)01362-8/fulltext

Safety and Feasibility of Autologous and Allogeneic Cell ... Ischemic wound complications associated with below-knee amputation (BKA) necessitate conversion to above-knee amputation (AKA) in up to 36% of cases.

9. sci.amegroups.org sci.amegroups.org/article/view/104230/html

Adverse events, side effects and complications in ... Clinical trials reported thromboembolism and fibrosis as the most common adverse events of MSCs therapy.