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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3 months, 6 months, and 12 months
Awards & highlights
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.
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.Check my eligibility
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.See study design
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 belowSelect...
My muscle volume in a specific area is between 100 - 280 cc, confirmed by MRI or CT.
Select...
I have compartment syndrome in my lower leg, including the front part.
Select...
My fracture is either not open, slightly open, or a minor open wound.
Select...
I am either not able to have children or I am using reliable birth control.
Select...
I am capable of becoming pregnant and have a negative pregnancy test.
Select...
My fracture is either not open, slightly open, or a minor open wound from the inside out.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy as determined by muscle strength
Safety as determined by incidence of combined adverse events related to study agent intervention
Secondary outcome measures
Ankle range of motion
Balance
Efficacy as determined by muscle regeneration
+10 moreTrial 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.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
979 Previous Clinical Trials
7,386,443 Total Patients Enrolled
Kenton W Gregory, MDPrincipal InvestigatorOregon Health and Science University
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have lost too much tissue for stem cell treatment to work.You are expected to live for less than a year.I cannot close a surgical wound on my leg or have burns that could affect healing.My muscle volume in a specific area is between 100 - 280 cc, confirmed by MRI or CT.My anterior tibialis muscle size is either below 100 cc or above 280 cc.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.I have compartment syndrome in my lower leg, including the front part.My doctor believes my wound can be closed.I have been diagnosed with chronic lower extremity vascular disease.I am unable to sign a consent form.I am expected to have an amputation of the limb affected by my condition.I am currently fighting an infection in my body.You have a neurological condition like a spinal cord injury or traumatic brain injury that could affect your ability to fully take part in the study's rehabilitation or could interfere with the study's measurements of balance and walking, as decided by the doctor.You have tested negative for HIV.I have not had cancer treatment in the last 5 years, except for basal cell carcinoma.I do not use a ventilator that would stop me from following rehabilitation plans.I am between 18 and 70 years old.I cannot or do not want to undergo standard physical therapy.I do not have leukemia, aplastic anemia, or lymphoma.My fracture is either not open, slightly open, or a minor open wound.I do not have any major health issues that would stop me from joining the study.I have a severe fracture in my leg.Your HbA1C levels are within the normal range at your healthcare provider's office.I have diabetes with high HbA1C levels, but it's under control.You have been diagnosed with HIV or have tested positive for HIV.I am either not able to have children or I am using reliable birth control.I am capable of becoming pregnant and have a negative pregnancy test.My fracture is either not open, slightly open, or a minor open wound from the inside out.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous BM-MNCs High Dose
- Group 2: Autologous BM-MNCs Low Dose
- Group 3: Observational Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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