Intramuscular administration of autologous BM-MNCs for Traumatic Lower Extremity Compartment Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Traumatic Lower Extremity Compartment SyndromeIntramuscular administration of autologous BM-MNCs - Biological
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if it is safe to give two different doses of a person's own bone marrow cells to treat lower extremity injuries complicated by compartment syndrome.

Eligible Conditions
  • Traumatic Lower Extremity Compartment Syndrome

Treatment Effectiveness

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: 6 weeks, 3 months, 6 months, and 12 months

Month 12
Efficacy as determined by muscle strength
Baseline and 6 months
Nerve conduction
Baseline through 12 months
Ankle range of motion
Efficacy as determined by muscle regeneration
Lower extremity sensation
Safety as determined by evidence of tumor formation
Wound healing
Baseline through 24 months
Questionnaire - Function
Questionnaire - Pain
Questionnaire - Physical Activity
Enrollment through 24 months
Safety as determined by incidence of combined adverse events related to study agent intervention
Month 12
Balance
Gait analysis
Gait endurance
Gait speed

Trial Safety

Trial Design

3 Treatment Groups

Observational Control
1 of 3
Autologous BM-MNCs High Dose
1 of 3
Autologous BM-MNCs Low Dose
1 of 3

Active Control

Experimental Treatment

18 Total Participants · 3 Treatment Groups

Primary Treatment: Intramuscular administration of autologous BM-MNCs · No Placebo Group · Phase 1

Autologous BM-MNCs High Dose
Biological
Experimental Group · 1 Intervention: Intramuscular administration of autologous BM-MNCs · Intervention Types: Biological
Autologous BM-MNCs Low Dose
Biological
Experimental Group · 1 Intervention: Intramuscular administration of autologous BM-MNCs · Intervention Types: Biological
Observational ControlNoIntervention Group · 1 Intervention: Observational Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 3 months, 6 months, and 12 months

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
893 Previous Clinical Trials
6,829,459 Total Patients Enrolled
Kenton W Gregory, MDPrincipal InvestigatorOregon Health and Science University

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a single or multiple compartment syndrome of the lower leg that includes the anterior tibial compartment.
Anterior compartment muscle volume between 100 - 280 cc as determined by MRI/CT.
HbA1C is within the clinical reference range for individuals aged 18 years or older.
You have a negative HIV test.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Oregon Health & Science University100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. Oregon Health & Science University: < 24 hours
Typically responds via
Email100.0%