BioACL Reconstruction With Amnion Collagen Matrix Wrap and Stem Cells Case Series

Completed · Phase 1

Conditions studied: ACL - Anterior Cruciate Ligament Rupture

In brief

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

Key facts

Study ID

NCT03294720

Run by

Andrews Research & Education Foundation

People needed

10

Starts

2018-01-08

Expected to finish

2022-12-31

Last updated by the study team

2023-02-01

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients between the ages of 18 and 35 who are scheduled to have anterior cruciate ligament reconstruction with autologous grafts by the principal investigator will be screened for participation in this study.
• Patients must be willing to undergo MRI scans post -operatively at 3, 6, 9 months and 1 year.

You may not qualify if…

• Patients with prior procedures or significant prior injuries to the same knee are excluded. Any patient who will have difficulty obtaining internet access, does not have an active e-mail address, or is unable to comprehend study documents or give informed consent will be excluded.
• Patient who are unable to complete MRI examinations due to claustrophobia or anxiety will be excluded.

Where it is running

• Andrews Institute — Gulf Breeze, Florida, United States

Full record on ClinicalTrials.gov

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