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NCT01386216 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)
A Phase 1 study, sponsored by Arteriocyte.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01386216: Completed Phase 1 study, sponsored by Arteriocyte.
NCT01386216 is a Phase 1 study that has completed, run by Arteriocyte. 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). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386216, a Phase 1 study, has completed, sponsored by Arteriocyte.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).
Primary Outcome
Treatment failure is defined as major amputation
Interventions
- DEVICE Magellan®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT01386216 record still lists
NCT01386216 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 0 conditions, and to 1 intervention - of which Magellan® is the first listed.
NCT01386216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01386216 about?
NCT01386216 is a clinical study titled "Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)". The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).
What is the current status of trial NCT01386216?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-04. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01386216?
The interventions under investigation include: Magellan® (DEVICE).
Who is sponsoring clinical trial NCT01386216?
This trial is sponsored by Arteriocyte, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01386216'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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