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NCT01837264 · ClinicalTrials.gov registry record · Phase 1
Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma
A Phase 1 study of Compartment Syndrome, sponsored by Arteriocyte.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT01837264: Completed Phase 1 study of Compartment Syndrome, sponsored by Arteriocyte.
NCT01837264 is a Phase 1 study of Compartment Syndrome that has completed, run by Arteriocyte. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01837264, a Phase 1 study of Compartment Syndrome, has completed, sponsored by Arteriocyte.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
Compartment syndrome (CS) is a condition resulting from increased pressure within a compartment, which compromises circulation and can lead to critical limb ischemia. CS is one of the biggest medical challenges that our soldiers face after battlefield related injuries. Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute compartment syndrome is a medical emergency requiring surgery. Treatment of compartment syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to evaluate the feasibility and safety of the administration of marrow-derived autologous bone marrow concentrate and PRP gel generated by a point of care marrow separation system for the treatment of compartment syndrome. And to show this treatment possibly enhances wound healing, bone healing, perfusion, infection control, and the return of limb function in patients with CS. Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and wound healing have predominantly focused on the mechanism of action of a single stem cell population to achieve neovascularization and improve tissue perfusion. It is well documented that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF, bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's development efforts focus on concentration of autologous bone marrow-derived stem cells and platelets for delivery to the site of injury in a concentration sufficient to effect local tissue revascularization and repair. These products provide for the rapid, bedside preparation of autologous PRP and bone marrow stem cell concentrate. This clinical trial with the Magellan® System is for the preparation of autologous cell concentrate for the treatment of wound, tissue and bone healing, improved perfusion, infection control, and the return of limb function in patients at risk of amputation.
Primary Outcome
* Measurement of rate of infection in the study population * Complications due to wound and/or therapy * Amputation of limb and/or death
Conditions Studied
Interventions
- DEVICE Magellan®
Study Locations (1)
Illinois
- Advocate Christ Medical Center - Oak Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 1 |
What the finished NCT01837264 record still lists
NCT01837264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Compartment Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Magellan® is the first listed.
NCT01837264 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01837264 about?
NCT01837264 is a clinical study titled "Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma". Compartment syndrome (CS) is a condition resulting from increased pressure within a compartment, which compromises circulation and can lead to critical limb ischemia. CS is one of the biggest medical challenges that our soldiers face after battlefield related injuries. Chronic or exercise-induced co...
What is the current status of trial NCT01837264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2013-01. Estimated completion is 2017-01-31.
What conditions does trial NCT01837264 study?
This clinical trial studies the following conditions: Compartment Syndrome.
What interventions are being tested in trial NCT01837264?
The interventions under investigation include: Magellan® (DEVICE).
Who is sponsoring clinical trial NCT01837264?
This trial is sponsored by Arteriocyte, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01837264 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01837264's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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