Bio ACL Reconstruction Amnion Collagen Matrix Wrap and Stem Cells (BioACLRCT)

February 19, 2024 updated by: Andrews Research & Education Foundation

Pilot Study: Augmentation of ACL Reconstruction With Bone Marrow Stem Cells and Amnion Collagen Matrix Wrap

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Histologic studies have determined that graft ligamentization following anterior cruciate ligament (ACL) reconstruction may take from 6 to 18 months. (1) It has been reported that incomplete graft maturation and incorporation is one cause of clinical graft failure. Animal studies have illustrated improved tendon healing/integration in ACL models augmented with stem cell technologies. (2-4). Basic scientists theorize that optimization of stem cell treatments for tissue regeneration requires that a "regenerative triad" be employed, i.e., use of a scaffold, stem cells and growth factors. In the intra-articular environment, research has shown that a scaffold such as an amnion wrap is necessary to contain the stem cells and growth factors in close proximity to the ACL graft. (2, 4, 5)

The normal, uninjured human ACL is covered by a layer of synovial tissue which contributes to the blood supply and nutrition of the native ACL. It is theorized that the lack of a synovial lining after injury and following traditional ACL reconstruction contributes to slow ligamentization and possible failure of reconstructed grafts.(5) Two studies have demonstrated accelerated maturation and ligamentization of human ACL graft augmented with point of care blood products. (6, 7) In one, leucocyte poor platelet rich plasma was injected directly into the body of the graft. (6) In the other, the platelet derived growth factors were loaded in a gelatin carrier which was wrapped around the graft. (7) In both studies accelerated and increased ligament maturation was documented compared to the controls. Collagen membranes derived from amniotic tissue have been successful to aid healing when used in difficult wounds and meniscal repair surgery. (8, 9)

The use of a collagen based -membrane derived from amniotic tissue may 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bio-ACL (Amion)
Intervention: ACL Autograft Reconstruction with Amion Collagen Scaffold. Stem Cells isolated from bone marrow aspirate from distal femur will be injected inside the Amion Collagen Scaffold.
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 Names:
  • Amnion
Active Comparator: Control
Intervention: Normal ACL Autograft Reconstruction with either patella or hamstring autograft will be performed in the control group.
Other: Control
Normal ACL reconstruction technique with either patella or hamstring autograft
Other Names:
  • Standard ACLr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ACL
Time Frame: 3 months, 6 months, 9 months, 12 months post-op
MRI region of interest mapping to produce mean T2 values
3 months, 6 months, 9 months, 12 months post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patient-reported pain rating
Time Frame: 3 months, 6 months, 9 months, 12 months post-op
Visual analog scale will be used to assess pain
3 months, 6 months, 9 months, 12 months post-op
Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 3 months, 6 months, 9 months, 12 months post-op
Patients will complete KOOS questionnaire on SOS
3 months, 6 months, 9 months, 12 months post-op
Changes in Short Form 12 (SF-12) patient ratings
Time Frame: 3 months, 6 months, 9 months, 12 months post-op
Patients will complete SF-12 questionnaire on SOS
3 months, 6 months, 9 months, 12 months post-op
Changes in Single Assessment Numerical Evaluation (SANE) patient ratings for function
Time Frame: 3 months, 6 months, 9 months, 12 months post-op
Patients will complete the SANE questionnaire on SOS
3 months, 6 months, 9 months, 12 months post-op
Marx Activity Scale Rating
Time Frame: 12 months post-op
Patients will complete the Marx Activity questionnaire on SOS
12 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Collaborators

Arthrex, Inc.

Investigators

  • Principal Investigator: Adam Anz, MD, Andrews Research & Education Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2017

Primary Completion (Actual)

December 6, 2023

Study Completion (Estimated)

December 6, 2024

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio ACL (RCT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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