Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03294759
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Andrews Research & Education Foundation

Brief 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

Condition or disease Intervention/treatment Phase
ACL - Anterior Cruciate Ligament Rupture Other: Bio ACL Other: Control 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)

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

ACL harvested for autograft reconstruction of the ACL with either hamstring or patellar tendon grafts. The graft will be wrapped in a collagen wrap and injection with aspirate from the patient's bone marrow.

The control group will have standard ACL reconstruction with either hamstring or patellar tendon grafts.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: Bone marrow aspirate will be collected through the surgical site from the distal femur with a trocar designed for this purpose. Therefore patients will be unable to determine if they have had stem cells harvested
Primary Purpose: Treatment
Official Title: Pilot Study: Augmentation of ACL Reconstruction With Bone Marrow Stem Cells and Amnion Collagen Matrix Wrap
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : September 19, 2020
Estimated Study Completion Date : February 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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 Name: 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 Name: Standard ACLr




Primary Outcome Measures :
  1. 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


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: 12 months post-op ]
    Patients will complete the Marx Activity questionnaire on SOS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03294759


Contacts
Layout table for location contacts
Contact: Adam Anz, MD (850) 916-8575 anz.adam.w@gmail.com
Contact: Steve Jordan, MD (850) 916-8575 jordan.se@gmail.com

Locations
Layout table for location information
United States, Florida
Andrews Institute Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Adam Anz, M.D.    334-728-1998    anz.adam.w@gmail.com   
Sponsors and Collaborators
Andrews Research & Education Foundation
Arthrex, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Adam Anz, MD Andrews Research & Education Foundation

Publications:

Layout table for additonal information
Responsible Party: Andrews Research & Education Foundation
ClinicalTrials.gov Identifier: NCT03294759     History of Changes
Other Study ID Numbers: Bio ACL (RCT)
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Layout table for additional information
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

Keywords provided by Andrews Research & Education Foundation:
amion
stem cell
acl

Additional relevant MeSH terms:
Layout table for MeSH terms
Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries