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

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ClinicalTrials.gov Identifier: NCT03294720
Recruitment Status : Active, not recruiting
First Posted : September 27, 2017
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Andrews Research & Education Foundation

Brief 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

Condition or disease Intervention/treatment Phase
ACL - Anterior Cruciate Ligament Rupture Procedure: Bio-ACL Device: amnion wrap and BMAC Not Applicable

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) Investigators believe that use of a 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Normal ACL reconstruction with either patellar or hamstring autograft will be done and prior to fixation the graft will be wrapped in a amion collagen wrap. Bone marrow aspirate will be obtained from distal femur at the time of the arthroscopy and stem cells isolated using the Arthrex Angel System. These stem cells with be under direct visualization impregnated into the ACL autograft amion wrap complex.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Augmentation of ACL Reconstruction With Bone Marrow Stem Cells and Amnion Collagen Matrix Wrap: a Case Series
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : December 25, 2020
Estimated Study Completion Date : March 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Bio ACL Reconstruction
Normal ACL reconstruction with either patellar or hamstring autograft will be done and prior to fixation the graft will be wrapped in a amion collagen wrap. Bone marrow aspirate will be obtained from distal femur at the time of the arthroscopy and stem cells isolated using the Arthrex Angel System. These stem cells with be under direct visualization impregnated into the ACL autograft amion wrap complex.
Procedure: Bio-ACL
ACL reconstruction with either hamstring or patellar autograft, wrapped in amion collagen wrap, and stem cells from bone marrow aspirate.

Device: amnion wrap and BMAC
amnion collagen wrap and bone-marrow aspirate in ACL reconstruction autograft




Primary Outcome Measures :
  1. MRI graft maturation and integration [ Time Frame: 3 months, 6 months, 9 months, and 12 months post-op ]
    validated T2 star sequence which will undergo region of interest mapping to produce mean T2 values. These values have been shown to detect differences in ACL content, structure and maturation.


Secondary Outcome Measures :
  1. 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

  2. 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. 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

  4. 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

  5. Marx Activity Scale Rating [ Time Frame: 3 months, 6 months, 9 months, 12 months post-op ]
    Patients will complete the Marx Activity questionnaire on SOS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294720


Locations
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United States, Florida
Andrews Institute
Gulf Breeze, Florida, United States, 32561
Sponsors and Collaborators
Andrews Research & Education Foundation
Arthrex, Inc.
Investigators
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Principal Investigator: Adam Anz, MD Andrews Insituite for Sports and Orthopaedics
Publications:

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Responsible Party: Andrews Research & Education Foundation
ClinicalTrials.gov Identifier: NCT03294720    
Other Study ID Numbers: BioACL (CS)
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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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
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries