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NCT03294720 · ClinicalTrials.gov registry record · Phase 1
BioACL Reconstruction With Amnion Collagen Matrix Wrap and Stem Cells Case Series
A Phase 1 study, sponsored by Andrews Research & Education Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03294720: Completed Phase 1 study, sponsored by Andrews Research & Education Foundation.
NCT03294720 is a Phase 1 study that has completed, run by Andrews Research & Education Foundation. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03294720, a Phase 1 study, has completed, sponsored by Andrews Research & Education Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the use of wrapping an ACL graft with a collagen matrix tissue wrap and injecting autologous bone marrow aspirate concentrate under the wrapping and into the graft. Investigators hypothesize that this method of augmenting ACL surgery will accelerate and improve the graft maturation and ligamentization process. Investigators propose to test this hypothesis with a series of cases of ACL reconstructions evaluated with post-operative MRI mapping sequences and validated clinical outcome measures
Primary Outcome
validated T2 star sequence which will undergo region of interest mapping to produce mean T2 values. These values have been shown to detect differences in ACL content, structure and maturation.
Interventions
- PROCEDURE Bio-ACL
- DEVICE amnion wrap and BMAC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-01-08 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 1 |
What the finished NCT03294720 record still lists
NCT03294720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Bio-ACL is the first listed.
NCT03294720 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03294720 about?
NCT03294720 is a clinical study titled "BioACL Reconstruction With Amnion Collagen Matrix Wrap and Stem Cells Case Series". The objective of this study is to evaluate the use of wrapping an ACL graft with a collagen matrix tissue wrap and injecting autologous bone marrow aspirate concentrate under the wrapping and into the graft. Investigators hypothesize that this method of augmenting ACL surgery will accelerate and imp...
What is the current status of trial NCT03294720?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2018-01-08. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03294720?
The interventions under investigation include: Bio-ACL (PROCEDURE), amnion wrap and BMAC (DEVICE).
Who is sponsoring clinical trial NCT03294720?
This trial is sponsored by Andrews Research & Education Foundation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03294720's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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