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A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation

NCT02685098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-09-23

No results posted yet for this study

Summary

Patients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complications after surgery and decrease the incidence of revision and further amputation. Cohort Groups 1-4 will serve as controls.

Conditions

  • Ischemia
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
  • Vascular Disease
  • Arterial Occlusive Disease
  • Arteriosclerosis
  • Atherosclerosis
  • Cardiovascular Disease
  • Pathologic Processes
  • Orthopedic Procedures
  • Amputation

Interventions

BIOLOGICAL

Allogeneic bone marrow derived mesenchymal stem cells

Injection of HLA-A2+ and/or gender mismatched allogeneic MSCs above the site of amputation and into the anterior tibialis muscle (ATM) of patients scheduled for semi-elective lower extremity major amputation at 7 days before amputation.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Michael P Murphy, MD · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2023-10-03
Completion
2023-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685098 on ClinicalTrials.gov