NCT03880656

BM-MNCs for Lower Extremity Compartment Syndrome Injury

Autologous Bone Marrow Mononuclear Cell Administration for Lower Extremity Compartment Syndrome Injury

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives are to assess safety and tolerability of a high and low dose of autologous bone marrow mononuclear cells. Secondary objectives include evaluation of potential responses of the BM-MNC therapy. This is a two-stage, randomized, unblinded, multicenter (two sites), controlled phase 1 clinical trial to evaluate the safety of two different doses of intramuscular injections of autologous bone marrow mononuclear cells, commonly known as a type of stem cell. Acute compartment syndrome injury is a mixed soft tissue injury due to a trauma that causes edema leading to excessive pressure in the muscle compartment. This type of injury frequently results in permanent reduction in function and disability. A total of 18 participants that have undergone a fasciotomy for treatment of a lower leg compartment syndrome will be enrolled with 6 assigned to the control (observational) group, 6 to the low cell-dose group and 6 to the high cell-dose group. The treatment arm will receive a single dose (high or low) of autologous BM-MNCs 5 - 9 days post injury and fasciotomy and a minimum of 3 months of standard of care physical rehabilitation. An observational control arm will not receive cells post fasciotomy but will undergo a standard of care course of physical therapy and will be followed for comparison to assess early safety signals and potential benefit.

Conditions

• Compartment Syndrome Traumatic Lower Extremity

Interventions

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

Timeline

• Start date: 2019-12-04
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2019-03-19
• Last updated: 2025-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study