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NCT01049919 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
A NA study, sponsored by Zimmer Biomet.
- Terminated
- Registry status
- NA
- Development phase
- 153
- Enrollment target
NCT01049919: Clinical Trial NA study, sponsored by Zimmer Biomet.
NCT01049919 is a NA study that was terminated before completion, run by Zimmer Biomet. The registered enrollment target is 153 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01049919, a NA study, was terminated before completion, sponsored by Zimmer Biomet.
- TERMINATED
- Registry status
- NA
- Development phase
- 153 participants
- Enrollment target
Study Summary
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial disease (PAD).
Primary Outcome
Occurrence of major amputation (above the ankle joint) or death.
Interventions
- DEVICE Bone marrow concentration device
- PROCEDURE Placebo procedure (sham)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2010-06 |
| Est. Completion | 2020-02 |
| Phase | NA |
Why NCT01049919 stopped before completion
NCT01049919 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Bone marrow concentration device is the first listed.
NCT01049919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01049919 about?
NCT01049919 is a clinical study titled "Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)". This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial disease (PAD).
What is the current status of trial NCT01049919?
This trial is currently terminated. It is a NA study. The enrollment target is 153 participants. The study started on 2010-06. Estimated completion is 2020-02.
What interventions are being tested in trial NCT01049919?
The interventions under investigation include: Bone marrow concentration device (DEVICE), Placebo procedure (sham) (PROCEDURE).
Who is sponsoring clinical trial NCT01049919?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01049919's enrollment target sits among peer trials
153 656th of 2000 higher than 1,343 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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