BM-MNCs for Lower Extremity Compartment Syndrome Injury

NCT03880656 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00018011
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Compartment Syndrome Traumatic Lower Extremity

Keywords

mononuclear cells

Outcome Measures

Primary Outcomes (2)

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

  Local and systemic reactions, serious adverse events and unexpected serious adverse events.

  Enrollment through 24 months

• Efficacy as determined by muscle strength

  Change in muscle strength compared to baseline and contralateral leg as measured by manual muscle testing and Biodex.

  6 weeks, 3 months, 6 months, and 12 months

Secondary Outcomes (13)

• Safety as determined by evidence of tumor formation

  Baseline through 12 months

• Efficacy as determined by muscle regeneration

  Baseline through 12 months

• Nerve conduction

  Baseline and 6 months

• Wound healing

  Baseline through 12 months

• Lower extremity sensation

  Baseline through 12 months

Study Arms (3)

Autologous BM-MNCs High Dose

EXPERIMENTAL

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

Biological: Intramuscular administration of autologous BM-MNCs

Observational Control

NO 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.

Autologous BM-MNCs Low Dose

EXPERIMENTAL

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

Biological: Intramuscular administration of autologous BM-MNCs

Interventions

Intramuscular administration of autologous BM-MNCs BIOLOGICAL

Intramuscular administration of autologous BM-MNCs at either a low or high cell dose.

Autologous BM-MNCs High Dose; Autologous BM-MNCs Low Dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior compartment syndrome of same limb;
• HIV positive as indicated by past medical history, self-report, or positive HIV test;
• Diagnosis of Type 1 or Type 2 diabetes with elevated HbA1C consistent with diabetes;(controlled diabetes acceptable, diabetes medication for other diagnosis acceptable)
• Diagnosis of chronic lower extremity vascular disease as diagnosed by current physician diagnosis, indicated in past medical history, or self-report if medical records do not accompany subject or are unable to be collected;
• Patients unable to sign an informed patient consent;
• Anticipated amputation of involved limb;
• Neurological conditions (i.e. spinal cord injury or traumatic brain injury) that may prevent full participation in CS rehabilitation or potentially confound study outcome measures (i.e. balance and gait) per physician discretion
• Current systemic infection;
• Local infection of the involved muscle group;
• Use of ventilator that would preclude rehabilitation protocols;
• Lack of access or unwillingness to complete standard of care course of physical therapy rehabilitation;
• Life expectancy 12 months or less;
• Bone marrow disorders (i.e. leukemia, aplastic anemia, lymphoma) ;
• Inability to close the fasciotomy wound or lower extremity burns that may affect wound closure
• Extensive tissue loss due to debridement resulting in insufficient residual tissue for stem cell administration and subsequent engraftment

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Study Officials

• Kenton W Gregory, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Oregon Center for Regenerative Medicine

Model Details: This is a two-stage, randomized, unblinded, multicenter (two sites), controlled phase 1 clinical trial.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: December 4, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)