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Bio ACL Reconstruction Amnion Collagen Matrix Wrap and Stem Cells

NCT03294759 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-21

No results posted yet for this study

Summary

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

Conditions

  • ACL - Anterior Cruciate Ligament Rupture

Interventions

OTHER

Bio ACL

Bone marrow aspirate will be centrifuged using the Arthrex Angel system to optimally concentrate the cells for implantation. The graft for the experimental groups will be wrapped with a sterile amnion matrix wrap, supplied by Arthrex

OTHER

Control

Normal ACL reconstruction technique with either patella or hamstring autograft

Sponsors & Collaborators

  • Arthrex, Inc.

    collaborator INDUSTRY

  • Andrews Research & Education Foundation

    lead OTHER

Principal Investigators

  • Adam Anz, MD · Andrews Research & Education Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2023-12-06
Completion
2024-12-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294759 on ClinicalTrials.gov