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NCT02863926 · ClinicalTrials.gov registry record · Phase 1
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
A Phase 1 study of Peripheral Artery Disease and Critical Limb Ischemia, sponsored by Michael Murphy.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT02863926: Completed Phase 1 study of Peripheral Artery Disease and Critical Limb Ischemia, sponsored by Michael Murphy.
NCT02863926 is a Phase 1 study of Peripheral Artery Disease and Critical Limb Ischemia that has completed, run by Michael Murphy. The registered enrollment target is 6 participants, below the 127-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02863926, a Phase 1 study of Peripheral Artery Disease and Critical Limb Ischemia, has completed, sponsored by Michael Murphy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
Primary Outcome
Safety will be evaluated by review of treatment related AEs during the 12-month follow-up period. The study will be terminated in the event of a Grade 4-5 unexpected event based on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-related AEs will be categorized overlapping systems and severities. Three categories of systems are cardiovascular, respiratory, or infectious. Two categories of severity will be serious adverse (SAE) and major adverse cardiac events (M
Conditions Studied
Interventions
- BIOLOGICAL Injection of cBMA aspirate into the index leg
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-01-06 |
| Est. Completion | 2018-07-27 |
| Phase | Phase 1 |
What the finished NCT02863926 record still lists
NCT02863926 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 127-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Injection of cBMA aspirate into the index leg is the first listed.
NCT02863926 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT02863926 about?
NCT02863926 is a clinical study titled "Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)". Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
What is the current status of trial NCT02863926?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-01-06. Estimated completion is 2018-07-27.
What conditions does trial NCT02863926 study?
This clinical trial studies the following conditions: Peripheral Artery Disease, Critical Limb Ischemia, Vascular Disease.
What interventions are being tested in trial NCT02863926?
The interventions under investigation include: Injection of cBMA aspirate into the index leg (BIOLOGICAL).
Who is sponsoring clinical trial NCT02863926?
This trial is sponsored by Michael Murphy, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02863926 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02863926's enrollment target sits among peer trials
6 51st of 50 the lowest of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease 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.
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