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

Primary Purpose

ACL - Anterior Cruciate Ligament Rupture

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bio-ACL

amnion wrap and BMAC

About this trial

This is an interventional treatment trial for ACL - Anterior Cruciate Ligament Rupture

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Andrews Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bio ACL Reconstruction

Arm 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.

Outcomes

Primary Outcome Measures

MRI graft maturation and integration

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

Changes in patient-reported pain rating

Visual analog scale will be used to assess pain

Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)

Patients will complete KOOS questionnaire on SOS

Changes in Short Form 12 (SF-12) patient ratings

Patients will complete SF-12 questionnaire on SOS

Changes in Single Assessment Numerical Evaluation (SANE) patient ratings for function

Patients will complete the SANE questionnaire on SOS

Marx Activity Scale Rating

Patients will complete the Marx Activity questionnaire on SOS

Full Information

NCT ID

NCT03294720

First Posted

September 20, 2017

Last Updated

January 30, 2023

Sponsor

Andrews Research & Education Foundation

Collaborators

Arthrex, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03294720

Brief Title

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

Acronym

BioACL(CS)

Official Title

Augmentation of ACL Reconstruction With Bone Marrow Stem Cells and Amnion Collagen Matrix Wrap: a Case Series

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 8, 2018 (Actual)

Primary Completion Date

August 31, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Andrews Research & Education Foundation

Collaborators

Arthrex, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ACL - Anterior Cruciate Ligament Rupture

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bio ACL Reconstruction

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Bio-ACL

Intervention Description

ACL reconstruction with either hamstring or patellar autograft, wrapped in amion collagen wrap, and stem cells from bone marrow aspirate.

Intervention Type

Device

Intervention Name(s)

amnion wrap and BMAC

Intervention Description

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

Primary Outcome Measure Information:

Title

MRI graft maturation and integration

Description

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.

Time Frame

3 months, 6 months, 9 months, and 12 months post-op

Secondary Outcome Measure Information:

Title

Changes in patient-reported pain rating

Description

Visual analog scale will be used to assess pain

Time Frame