BM-MNCs for Lower Extremity Compartment Syndrome Injury

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2025 → Dec 2027
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Record History

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  1. Primary completion pushed from Dec 2025 to Dec 2027 Show 4 more changesShow less
    • Study completion pushed from Jun 2026 to Jun 2028
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 6 of 13 entries
    • Site details revised
  2. Re-verified, no change to tracked fieldsv9
  3. Primary completion date: Dec 2023 to Dec 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2024 to Jun 2026
    • Site details revised
    v8
  4. Study sites: 2 to 1v7
  5. Primary completion date: Jun 2021 to Dec 2023
    • Study completion date: Dec 2021 to Jun 2024
    • Eligibility criteria expanded, about 10 words
    • Collaborators shortened, about 3 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2019 to Dec 4, 2019
    • Site details revised at 2 of 2 sites
    v5
  2. Start date: Jul 2019 to Dec 2019
    • Eligibility criteria shortened, about 23 words
    v4
  3. Start date: Mar 2019 to Jul 2019
    • Primary completion date: Mar 2021 to Jun 2021
    v3
  4. Secondary endpoints: details revised at 3 of 13 entriesv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03880656
Lead Sponsor Oregon Health and Science University
Conditions
(from sponsor)		 Compartment Syndrome Traumatic Lower Extremity
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov