What is the mechanism of action of this treatment?

Lower Extremity Compartment Syndrome (LECS) is typically treated with surgical intervention, such as fasciotomy, to relieve pressure and restore blood flow. However, regenerative therapies like autologous bone marrow mononuclear cells (BM-MNCs) are being studied for their potential to enhance tissue repair and regeneration. BM-MNCs work by promoting angiogenesis, reducing inflammation, and differentiating into various cell types that can repair damaged tissues. This is particularly important for LECS patients as it may improve functional recovery and reduce the long-term complications associated with muscle and nerve damage.

What side effects are associated with this type of intervention?

Common treatments for Lower Extremity Compartment Syndrome (LECS) include surgical interventions like fasciotomy and investigational therapies such as the administration of autologous bone marrow mononuclear cells (BM-MNCs). Fasciotomy, which involves cutting the fascia to relieve pressure, can lead to complications such as infection, nerve damage, and delayed wound healing. In the context of regenerative therapies like BM-MNCs, side effects are generally minimal but can include pain, bleeding, tenderness, swelling, and bruising at the injection site. Additionally, there is a risk of local infection associated with any intramuscular injection.

What prior FDA approvals exist?

There are no specific FDA-approved drugs or treatments for Lower Extremity Compartment Syndrome that utilize autologous bone marrow mononuclear cells (BM-MNCs) or similar regenerative and reparative mechanisms. Current standard treatments primarily involve surgical intervention, such as fasciotomy, to relieve pressure and restore blood flow. Research and clinical trials, like the phase 1 study mentioned, are ongoing to explore the safety and efficacy of BM-MNCs for this condition.

What other types of research exist?

Promising novel alternatives to Autologous Bone Marrow Mononuclear Cells for Lower Extremity Compartment Syndrome include: 1) Mesenchymal Stem Cells (MSCs) combined with tissue-engineering scaffolds, which are being investigated for their potential to treat massive posttraumatic muscle loss and postdenervation muscle injury. 2) Platelet-Rich Plasma (PRP) injections, which are being explored for various musculoskeletal conditions, although their routine use is not yet recommended. 3) CD34+ cell therapy, which has shown significant improvements in muscle perfusion, pain-free walking time, and other clinical outcomes in patients with severe lower extremity arterial ischemia.

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Stem Cell Therapy

BM-MNC Therapy for Compartment Syndrome

Phase 1

Waitlist Available

Led By Kenton W Gregory, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Anterior compartment muscle volume between 100 - 280 cc as determined by MRI/CT

Has single or multiple compartment syndrome of the lower leg that includes the anterior tibial compartment

Must not have

Local infection of the involved muscle group

Evidence of any past or present clinically significant medical condition that would impair wound healing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 3 months, 6 months, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a phase 1 study primarily assessing safety, specific side effects are being monitored but may include typical reactions related to intramuscular injections such as pain at injection site, infection risk, and potential immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have compartment syndrome in my lower leg, including the front part.

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My fracture is either not open, slightly open, or a minor open wound.

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I am either not able to have children or I am using reliable birth control.

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I am capable of becoming pregnant and have a negative pregnancy test.

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My fracture is either not open, slightly open, or a minor open wound from the inside out.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have lost too much tissue for stem cell treatment to work.

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I cannot close a surgical wound on my leg or have burns that could affect healing.

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My anterior tibialis muscle size is either below 100 cc or above 280 cc.

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I am unable to sign a consent form.

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I am expected to have an amputation of the limb affected by my condition.

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I am currently fighting an infection in my body.

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I do not use a ventilator that would stop me from following rehabilitation plans.

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I cannot or do not want to undergo standard physical therapy.

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I do not have leukemia, aplastic anemia, or lymphoma.

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I have a severe fracture in my leg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 3 months, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 3 months, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3 months, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy as determined by muscle strength

Safety as determined by incidence of combined adverse events related to study agent intervention

Secondary study objectives

Ankle range of motion

Balance

Efficacy as determined by muscle regeneration

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Autologous BM-MNCs Low DoseExperimental Treatment1 Intervention

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

Group II: Autologous BM-MNCs High DoseExperimental Treatment1 Intervention

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

Group III: Observational ControlActive Control1 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.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lower Extremity Compartment Syndrome (LECS) is typically treated with surgical intervention, such as fasciotomy, to relieve pressure and restore blood flow. However, regenerative therapies like autologous bone marrow mononuclear cells (BM-MNCs) are being studied for their potential to enhance tissue repair and regeneration. BM-MNCs work by promoting angiogenesis, reducing inflammation, and differentiating into various cell types that can repair damaged tissues. This is particularly important for LECS patients as it may improve functional recovery and reduce the long-term complications associated with muscle and nerve damage.

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