MedTrace Logo

BM-MNCs for Lower Extremity Compartment Syndrome Injury

NCT03880656 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-04-03

No results posted yet for this study

Summary

This is a phase 1 study to assess safety and tolerability of intramuscular administration of two different doses of autologous bone marrow mononuclear cells (BM-MNCs) for treatment of lower extremity injury complicated by compartment syndrome injury.

Conditions

  • Compartment Syndrome Traumatic Lower Extremity

Interventions

BIOLOGICAL

Intramuscular administration of autologous BM-MNCs

Intramuscular administration of autologous BM-MNCs at either a low or high cell dose.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Kenton W Gregory, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-04
Primary Completion
2025-12-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03880656 on ClinicalTrials.gov