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Stem Cell Therapy

Injection of cBMA aspirate into the index leg for Peripheral Arterial Disease (MarrowCHAMP Trial)

Phase 1

Waitlist Available

Led By Michael P Murphy, MD

Research Sponsored by Michael Murphy

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 12 month period

Awards & highlights

MarrowCHAMP Trial Summary

This trial is testing whether bone marrow cells can prevent ischemic wound complications after major extremity lower amputation surgery.

Eligible Conditions

Peripheral Arterial Disease
Critical Limb Ischemia
Vascular Disease

MarrowCHAMP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ primary follow up in a 12 month period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~primary follow up in a 12 month period

This trial's timeline: 3 weeks for screening, Varies for treatment, and primary follow up in a 12 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

The role of MSCs injected in human skeletal muscle at the time of below knee amputation as evidenced by recruitment of proangiogenic hematopoietic cells into sites of ischemia.

Time period of retention of allogeneic MSCs in harvested human skeletal muscle tissue post-MSC implantation as measured by immunohistochemical staining and number of MSCs per section of skeletal muscle at each time point .

MarrowCHAMP Trial Design

3Treatment groups

Experimental Treatment

Group I: Day 7Experimental Treatment1 Intervention

BKA performed at 7 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg

Group II: Day 21Experimental Treatment1 Intervention

BKA performed at 21 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg

Group III: Day 14Experimental Treatment1 Intervention

BKA performed at 14 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Injection of cBMA aspirate into the index leg

2017

Completed Phase 1

~10

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Who is running the clinical trial?

Michael MurphyLead Sponsor

Zimmer BiometIndustry Sponsor

373 Previous Clinical Trials

67,389 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

158 Patients Enrolled for Peripheral Arterial Disease

Michael P Murphy, MDPrincipal InvestigatorIndiana University

3 Previous Clinical Trials

116 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

116 Patients Enrolled for Peripheral Arterial Disease

Media Library

Autologous Concentrated Bone Marrow Aspirate (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02863926 — Phase 1

Peripheral Arterial Disease Research Study Groups: Day 14, Day 7, Day 21

Peripheral Arterial Disease Clinical Trial 2023: Autologous Concentrated Bone Marrow Aspirate Highlights & Side Effects. Trial Name: NCT02863926 — Phase 1

Autologous Concentrated Bone Marrow Aspirate (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02863926 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enrol in this clinical experiment at present?

"As reported on clinicaltrials.gov, this trial is not currently recruiting patients and has been in its current state since September 29th 2022. Though no longer an option for participants, 663 other medical studies are open to recruitment at present."

Answered by AI

Is the injection of cBMA aspirate into the index leg a safe procedure for people?

"Limited data exists in regards to the safety and efficacy of injection of cBMA aspirate into the index leg, leading our team at Power to assign it a score of 1."

Answered by AI

Is the upper age limit for this experiment greater than or equal to 85?

"This trial requires applicants aged 40 to 90. In contrast, there are 47 trials targeting minors and 623 studies aimed at adults above the age of 65."

Answered by AI