BM-MNC Therapy for Compartment Syndrome

Recruiting at 1 trial location

Overseen By Natalie C Pettigrew, DPT

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Oregon Health and Science University

Disqualifiers: Active malignancy, HIV positive, Diabetes, Vascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing the safety of using a patient's own stem cells to treat severe leg injuries. It targets patients who have had surgery for serious muscle damage. The stem cells are injected to help heal the muscle.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have controlled diabetes, taking diabetes medication is acceptable.

How does BM-MNC therapy differ from other treatments for compartment syndrome?

BM-MNC therapy involves injecting a patient's own bone marrow cells directly into the muscle, which is different from the standard treatment of fasciotomy that involves cutting the muscle to relieve pressure. This therapy aims to promote tissue regeneration and recovery, offering a potentially less invasive and more regenerative approach. ^{1 2 3 4 5}

Who Is on the Research Team?

Kenton Gregory, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

Adults aged 18-70 with lower extremity compartment syndrome requiring fasciotomy, able to consent and follow a rehab program for 24 months. Must have negative HIV test, no severe fractures or neurological conditions that affect rehabilitation, and not be on ventilators. Women of childbearing age must use contraception and have a negative pregnancy test.

Inclusion Criteria

My muscle volume in a specific area is between 100 - 280 cc, confirmed by MRI or CT.

I had surgery to relieve pressure in my leg and am eligible for a specific cell therapy between day 5-9 after.

I am willing and able to complete standard rehab therapy and follow-up for 2 years.

Exclusion Criteria

I have an infection in the muscles where my condition is located.

You had compartment syndrome in the same arm or leg before.

I have a condition that could affect how my wounds heal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of autologous BM-MNCs 5-9 days post-injury and fasciotomy, followed by a minimum of 3 months of standard of care physical rehabilitation

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscle strength, pain, gait, wound healing, and other secondary outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Intramuscular administration of autologous BM-MNCs

Trial Overview The trial is testing the safety of injecting different doses of patients' own bone marrow mononuclear cells (BM-MNCs) into their muscles to treat injuries from compartment syndrome in the lower legs.

How Is the Trial Designed?

Group I: Autologous BM-MNCs Low Dose Experimental Treatment 1 Intervention

Administration of autologous bone marrow mononuclear cells at a Low dose (350,000 cells/cc of tissue)

Group II: Autologous BM-MNCs High Dose Experimental Treatment 1 Intervention

Administration of autologous bone marrow mononuclear cells at High dose (700,000 cells/cc of tissue)

Group III: Observational Control Active Control 1 Intervention

Standard of care provided for subjects that have undergone a fasciotomy following a diagnosis of compartment syndrome. No autologous bone marrow mononuclear cells will be administered.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Compression-induced muscle injury in rats that mimics compartment syndrome in humans. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

A rabbit model of peripheral compartment syndrome with associated rhabdomyolysis and a regenerative medicine approach for treatment. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Targeting widespread sites of damage in dystrophic muscle: engrafted macrophages as potential shuttles. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Further development of a tissue engineered muscle repair construct in vitro for enhanced functional recovery following implantation in vivo in a murine model of volumetric muscle loss injury. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiosphere-derived cells, with and without a biological scaffold, stimulate myogenesis and recovery of muscle function in mice with volumetric muscle loss. [2021]