Intramuscular administration of autologous BM-MNCs for Traumatic Lower Extremity Compartment Syndrome
Phase-Based Progress Estimates
Effectiveness
Safety
Traumatic Lower Extremity Compartment SyndromeIntramuscular administration of autologous BM-MNCs - Biological
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
Effectiveness Progress
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
Safety Progress
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: BiologicalAutologous BM-MNCs Low Dose
Biological
Experimental Group · 1 Intervention: Intramuscular administration of autologous BM-MNCs · Intervention Types: BiologicalObservational 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?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Oregon Health & Science University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Average response time
- < 1 Day
Most responsive sites:
- Oregon Health & Science University: < 24 hours
Typically responds via
| 100.0% | |
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