Compartment Syndrome Traumatic Lower ExtremityPhase 1NCT03880656
BM-MNCs for Lower Extremity Compartment Syndrome Injury
A Phase 1 study testing Intramuscular administration of autologous BM-MNCs in people with Compartment Syndrome Traumatic Lower Extremity, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Compartment Syndrome Traumatic Lower Extremity
- What is being tested?
- Intramuscular administration of autologous BM-MNCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2019to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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-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;
Show all 21Show fewer
- 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
- Lower extremity compound fracture type II or III (Gustilo-Anderson classification);
- Anterior tibialis muscle volume less than 100 cc or greater than 280 cc as determined by MRI/CT;
- Evidence of any past or present clinically significant medical condition that would impair wound healing
- History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study as determined by the investigator or the investigator's designee;
- Any reason, considered by the principal investigator or designee, to preclude subject enrollment in the study that might represent a threat to the subject's health or safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Autologous Bone Marrow Mononuclear Cell Administration for Lower Extremity Compartment Syndrome Injury
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.
Read the detailed description
The primary objectives are to assess safety and tolerability of a high and low dose of autologous bone marrow mononuclear cells. Secondary objectives include evaluation of potential responses of the BM-MNC therapy.
This is a two-stage, randomized, unblinded, multicenter (two sites), controlled phase 1 clinical trial to evaluate the safety of two different doses of intramuscular injections of autologous bone marrow mononuclear cells, commonly known as a type of stem cell. Acute compartment syndrome injury is a mixed soft tissue injury due to a trauma that causes edema leading to excessive pressure in the muscle compartment. This type of injury frequently results in permanent reduction in function and disability.
A total of 18 participants that have undergone a fasciotomy for treatment of a lower leg compartment syndrome will be enrolled with 6 assigned to the control (observational) group, 6 to the low cell-dose group and 6 to the high cell-dose group. The treatment arm will receive a single dose (high or low) of autologous BM-MNCs 5 - 9 days post injury and fasciotomy and a minimum of 3 months of standard of care physical rehabilitation. An observational control arm will not receive cells post fasciotomy but will undergo a standard of care course of physical therapy and will be followed for comparison to assess early safety signals and potential benefit.
- Being tested
- Intramuscular administration of autologous BM-MNCs
- Keywords
- mononuclear cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular administration of autologous BM-MNCsBiological
Intramuscular administration of autologous BM-MNCs at either a low or high cell dose.
| Study group | Role | What they receive |
|---|---|---|
| Autologous BM-MNCs High Dose | Experimental | Administration of autologous bone marrow mononuclear cells at High dose (700,000 cells/cc of tissue) Receives: 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) Receives: Biological: Intramuscular administration of autologous BM-MNCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks, 3 months, 6 months, and 12 months
Secondary outcomes (13)
Safety as determined by evidence of tumor formation
Magnetic resonance imaging (MRI) and/or computed tomography (CT)
Measured: Baseline through 12 months
Efficacy as determined by muscle regeneration
Magnetic resonance imaging (MRI) and/or computed tomography (CT) to measure muscle volume
Measured: Baseline through 12 months
Nerve conduction
Nerve conduction velocity test
Measured: Baseline and 6 months
Wound healing
Number of days until wound closure at the site of fasciotomy of the anterior compartment.
Measured: Baseline through 12 months
Lower extremity sensation
Sensation as measured by Semmes Weinstein Monofilament.
Measured: Baseline through 12 months
Ankle range of motion
Range of Motion (ROM): active and passive dorsi/plantar flexion ROM assessed using a goniometer.
Measured: Baseline through 12 months
Gait analysis
Change in gait kinematics: gait will be recorded using a Tekscan Pressure Mapping system where each sequential footstep is recorded along with synchronized video.
Measured: Week 6 through 12 months
Gait endurance
Gait endurance measured using the 6-Minute Walk Test.
Measured: Week 6 through 12 months
Gait speed
Gait speed measured using the 10 Meter Walk Test.
Measured: Week 6 through 12 months
Balance
Balance assessed by single limb stance time.
Measured: Week 6 through 12 months
Questionnaire - Pain
Pain measured using the Numeric Pain Rating Scale (NPRS). The participant is asked to make three pain ratings (0 to 10; 0 - no pain, 10 - worst pain), corresponding to current, best and worst pain experienced over the past 24 hours. The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours.
Measured: Baseline through 24 months
Questionnaire - Function
Lower extremity function assessed using the Lower Extremity Functional Scale (LEFS). Total score (0 to 80; higher score = better outcome) is reported as a sum of 20 responses regarding functional activities (0 - extreme difficulty or unable to perform, 4 - no difficulty).
Measured: Baseline through 24 months
Questionnaire - Physical Activity
Physical activity measured by the international physical activity questionnaire (IPAQ). Scores are reported as categorical (low, moderate, high) and/or continuous (metabolic equivalent minutes per week).
Measured: Baseline through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start4 Dec 2019
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment Syndrome Traumatic Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-stage, randomized, unblinded, multicenter (two sites), controlled phase 1 clinical trial.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenton W. Gregory, Oregon Health and Science University
- Investigators
- Kenton W Gregory, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880656
- Sponsor's protocol ID
- STUDY00018011
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2019
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Mononuclear Cell Administration for Lower Extremity Compartment Syndrome Injury
- ClinicalTrials.gov ID
- NCT03880656
- Acronym / sponsor ID
- STUDY00018011
- Keywords
- mononuclear cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objectives are to assess safety and tolerability of a high and low dose of autologous bone marrow mononuclear cells. Secondary objectives include evaluation of potential responses of the BM-MNC therapy.
This is a two-stage, randomized, unblinded, multicenter (two sites), controlled phase 1 clinical trial to evaluate the safety of two different doses of intramuscular injections of autologous bone marrow mononuclear cells, commonly known as a type of stem cell. Acute compartment syndrome injury is a mixed soft tissue injury due to a trauma that causes edema leading to excessive pressure in the muscle compartment. This type of injury frequently results in permanent reduction in function and disability.
A total of 18 participants that have undergone a fasciotomy for treatment of a lower leg compartment syndrome will be enrolled with 6 assigned to the control (observational) group, 6 to the low cell-dose group and 6 to the high cell-dose group. The treatment arm will receive a single dose (high or low) of autologous BM-MNCs 5 - 9 days post injury and fasciotomy and a minimum of 3 months of standard of care physical rehabilitation. An observational control arm will not receive cells post fasciotomy but will undergo a standard of care course of physical therapy and will be followed for comparison to assess early safety signals and potential benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a two-stage, randomized, unblinded, multicenter (two sites), controlled phase 1 clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Autologous BM-MNCs High Dose | Experimental | Biological: Intramuscular administration of autologous BM-MNCsAdministration of autologous bone marrow mononuclear cells at High dose (700,000 cells/cc of tissue) |
| 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 | Biological: Intramuscular administration of autologous BM-MNCsAdministration of autologous bone marrow mononuclear cells at a Low dose (350,000 cells/cc of tissue) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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-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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular administration of autologous BM-MNCsIntramuscular administration of autologous BM-MNCs at either a low or high cell dose. | Biological | Autologous BM-MNCs High Dose, Autologous BM-MNCs Low Dose |
Primary outcome
Safety as determined by incidence of combined adverse events related to study agent intervention
Time frame: Enrollment through 24 months
Local and systemic reactions, serious adverse events and unexpected serious adverse events.
Efficacy as determined by muscle strength
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Change in muscle strength compared to baseline and contralateral leg as measured by manual muscle testing and Biodex.
13 secondary outcomes
Safety as determined by evidence of tumor formation
Time frame: Baseline through 12 months
Efficacy as determined by muscle regeneration
Time frame: Baseline through 12 months
Nerve conduction
Time frame: Baseline and 6 months
Wound healing
Time frame: Baseline through 12 months
Lower extremity sensation
Time frame: Baseline through 12 months
Ankle range of motion
Time frame: Baseline through 12 months
Gait analysis
Time frame: Week 6 through 12 months
Gait endurance
Time frame: Week 6 through 12 months
Gait speed
Time frame: Week 6 through 12 months
Balance
Time frame: Week 6 through 12 months
Questionnaire - Pain
Time frame: Baseline through 24 months
Questionnaire - Function
Time frame: Baseline through 24 months
Questionnaire - Physical Activity
Time frame: Baseline through 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Compartment Syndrome Traumatic Lower Extremity
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenton W Gregory, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intramuscular administration of autologous BM-MNCs in people with Compartment Syndrome Traumatic Lower Extremity, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as determined by incidence of combined adverse events related to study agent intervention (time frame: Enrollment through 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.