Bio ACL Reconstruction Amnion Collagen Matrix Wrap and Stem Cells

Status unconfirmed · Not applicable

Conditions studied: ACL - Anterior Cruciate Ligament Rupture

In brief

Collagen based -membrane derived from amniotic tissue can be used to help reestablish the natural synovial lining of the reconstructed ACL, in effect acting as both a barrier from the synovial fluid and as a scaffold to contain autologous mesenchymal stem cells and growth factors contiguous with the graft, thus aiding and perhaps accelerating the natural maturation and ligamentization process of the implanted graft tissue. Acceleration and improvement in graft maturation and strength would be a significant advancement in sports medicine allowing safer and earlier return to sports and activity

Key facts

Study ID

NCT03294759

Run by

Andrews Research & Education Foundation

People needed

40

Starts

2017-09-06

Expected to finish

2024-12-06

Last updated by the study team

2024-02-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients between the ages of 18 and 45 who are scheduled to have anterior cruciate ligament reconstruction with autologous grafts by one of the investigating physicians 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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