BM-MNC Therapy for Compartment Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and tolerability of using a person's own bone marrow cells, administered through muscle injections, to treat compartment syndrome in the lower leg. Compartment syndrome causes swelling in the muscles, leading to severe pain and tissue damage. Participants will join one of two groups receiving different cell doses or a group receiving standard care without the cell treatment. The trial seeks individuals who have undergone surgery (fasciotomy) for compartment syndrome in the lower leg and can begin treatment 5-9 days post-surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have found treatments using a person's own bone marrow cells safe for other conditions. For example, research on patients with stroke and cerebral palsy (a disorder affecting movement) showed that this treatment was well-tolerated, with no major side effects, suggesting safety.
The current trial is an early-phase study, primarily focused on assessing safety. While this specific study is new, using these bone marrow cells in other treatments has not caused serious problems. This provides some confidence in its safety, but new trials are essential to verify these findings for different conditions. Participants in this study will help confirm the safety of these bone marrow cells for compartment syndrome.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using autologous bone marrow mononuclear cells (BM-MNCs) for treating compartment syndrome because they offer a novel approach compared to traditional surgical interventions like fasciotomy. Unlike standard treatments that focus on relieving pressure through surgery, BM-MNC therapy involves injecting a patient's own bone marrow cells directly into the muscle, which might promote faster healing and tissue regeneration. The trial is exploring both high and low doses of these cells, which could provide insights into the optimal amount needed for effective treatment. This method could reduce recovery time and improve outcomes by harnessing the body's natural healing processes.
What evidence suggests that this trial's treatments could be effective for compartment syndrome?
Research has shown that using a person's own bone marrow cells holds promise in various treatments. One study found these cells to be safe and effective for patients with severe liver disease, significantly improving their condition. Other research suggests these cells can enhance movement in children with certain conditions. Additionally, in patients with severe blood flow problems in their limbs, these cells improved circulation and reduced symptoms. In this trial, participants will receive either a high dose or a low dose of autologous bone marrow mononuclear cells, or they will be part of an observational control group receiving standard care. These findings suggest that bone marrow cells might aid in healing and repairing tissues, making them a potential treatment for injuries related to compartment syndrome.46789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of muscle strength, pain, gait, wound healing, and other secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Intramuscular administration of autologous BM-MNCs
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor