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NCT03880656 · ClinicalTrials.gov registry record · Phase 1

BM-MNCs for Lower Extremity Compartment Syndrome Injury

A Phase 1 study of Compartment Syndrome Traumatic Lower Extremity, sponsored by Oregon Health and Science University.

Active
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT03880656: Active Phase 1 study of Compartment Syndrome Traumatic Lower Extremity, sponsored by Oregon Health and Science University.

NCT03880656 is a Phase 1 study of Compartment Syndrome Traumatic Lower Extremity that is active but no longer recruiting, run by Oregon Health and Science University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03880656, a Phase 1 study of Compartment Syndrome Traumatic Lower Extremity, is active but no longer recruiting, sponsored by Oregon Health and Science University.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Interventions

  • BIOLOGICAL Intramuscular administration of autologous BM-MNCs

Study Locations (1)

Oregon

  • Oregon Health & Science University - Portland

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2019-12-04
Est. Completion 2026-06
Phase Phase 1

What the registry record for NCT03880656 still lists

NCT03880656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 1 condition, with Compartment Syndrome Traumatic Lower Extremity appearing as the primary indexed condition, and to 1 intervention - of which Intramuscular administration of autologous BM-MNCs is the first listed.

NCT03880656 reports a single indexed study location in Oregon.

Frequently Asked Questions

What is clinical trial NCT03880656 about?

NCT03880656 is a clinical study titled "BM-MNCs 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.

What is the current status of trial NCT03880656?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-12-04. Estimated completion is 2026-06.

What conditions does trial NCT03880656 study?

This clinical trial studies the following conditions: Compartment Syndrome Traumatic Lower Extremity.

What interventions are being tested in trial NCT03880656?

The interventions under investigation include: Intramuscular administration of autologous BM-MNCs (BIOLOGICAL).

Who is sponsoring clinical trial NCT03880656?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03880656 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03880656's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03880656, the US trial registry maintained by the National Library of Medicine. NCT03880656 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.