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BM-MNC Therapy for Compartment Syndrome
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Autologous BM-MNCs High Dose
- Group 2: Autologous BM-MNCs Low Dose
- Group 3: Observational Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there currently opportunities for individuals to participate in this scientific experiment?
"According to the clinicaltrials.gov record, this medical experiment is still open for patient recruitment. The initial posting was on December 4th 2019 and the latest update occurred on June 29th 2022."
Has the FDA sanctioned intramuscular injection of autologous BM-MNCs?
"According to our team at Power, the safety of Intramuscular administration of autologous BM-MNCs can be rated a 1. This is due to it being classified as a Phase 1 trial and therefore having limited evidence supporting its efficacy or safety."
What is the original goal of this experiential research?
"The 6-week, 3-month, 6-month, and 12-month clinical trial is designed to gauge the safety of a new agent based on combined adverse events. Secondary endpoints include ankle range of motion as measured by goniometry, evidence of tumor formation via MRI or CT scans, and lower extremity sensation using Semmes Weinstein Monofilament tests."
Are adults over 35 years old eligible to partake in this trial?
"This trial has a minimum age requirement of 18 and an upper limit of 70 years old."
Are there any criteria that must be met in order to engage with this experiment?
"This clinical trial seeks to recruit 18 medically-eligible individuals aged 18 - 70 with compartment syndromes. These patients should meet the following criteria: of both sexes and between those two ages, trauma victims needing fasciotomy treatable using autologous BM-MNC therapy in post-fasciotomy days 5 - 9, able to sign an informed consent form, willing and capable of undergoing standard rehabilitation treatment and 24 months follow up evaluations, skilled in closing their own wound upon physician assessment (non-fracture or closed fracture type I Gustilo Anderson classification), single or multiple lower leg anterior tibial compartments with"
What is the current number of participants in this investigation?
"Indeed, the information on clinicaltrials.gov suggests that this research is currently enrolling patients. This trial was first published in December of 2019 and modified as recently at June 29th 2022; it seeks to find 18 test subjects from two medical facilities."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Oregon Health & Science University: < 24 hours
Average response time
- < 1 Day
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