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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 is a Phase 1 study that has completed, run by Andrews Research & Education Foundation. The registered enrollment target is 10 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03294720
The ClinicalTrials.gov registry entry for NCT03294720 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Andrews Research & Education Foundation, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bio-ACL is the first listed.
NCT03294720 reports 0 study locations.
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.
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