BM-MNCs for Lower Extremity Compartment Syndrome Injury
United States18 participantsStarted 2019-12-04
Plain-language summary
This is a phase 1 study to assess safety and tolerability of intramuscular administration of two different doses of autologous bone marrow mononuclear cells (BM-MNCs) for treatment of lower extremity injury complicated by compartment syndrome injury.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Females and males 18 - 70 years old
* Has single or multiple compartment syndrome of the lower leg that includes the anterior tibial compartment
* Trauma patients with lower extremity CS requiring fasciotomy that can be treated with autologous BM-MNC therapy on day 5-9 post-fasciotomy
* Ability to sign an informed patient consent form
* Access and willingness to complete a standard of care course of rehabilitation therapy and 24 months follow-up evaluations
* Ability to close the fasciotomy wound per physician assessment
* Anterior compartment muscle volume between 100 - 280 cc as determined by MRI/CT
* Within the institutions' clinical reference ranges for HbA1C
* Negative HIV test
· - Non-fracture, closed fracture or compound fracture type I (wound less than 1cm \& compound from within out) (Gustilo-Anderson classification)
* Female subjects must be of non-childbearing potential or must be using adequate contraception
* If female subject is of childbearing potential, subject must have a negative pregnancy test at screening
* Willing and able to adhere to the study schedule
Exclusion Criteria:
* Prior compartment syndrome of same limb;
* Active malignancy or has undergone treatment for a malignancy in the preceding 5 years as indicated in past medical history or self-report if medical records do not accompany subject or are unable to be collected (basal cell carcinoma non-exclusionary);
* HIV positive as indicated by past medical history, self-rep…
What they're measuring
1
Safety as determined by incidence of combined adverse events related to study agent intervention
Timeframe: Enrollment through 24 months
2
Efficacy as determined by muscle strength
Timeframe: 6 weeks, 3 months, 6 months, and 12 months