Augmentation of Anterior Cruciate Ligament Reconstruction Using Mesenchymal Stem Cells and Collagen Matrix Carrier (BioACL)

February 9, 2023 updated by: Andrews Research & Education Foundation

A Randomized, Single Blinded Study of the Augmentation of Anterior Cruciate Ligament Reconstruction Using Stump-Derived Mesenchymal Stem Cells Versus Standard of Care Anterior Cruciate Ligament Reconstruction

The goal of this observational study is to compare patient outcomes for reconstructive surgery of ACL tears. This study utilizes two randomized groups, one being the control group that receives standard ACL reconstructive surgery, while the other is the test group at will receive an injection of stem cells taken from elsewhere within the body. The main objectives are to determine the usefulness of stem cells as a cost-effective implant in reconstructive surgery and to determine if the stem cells provide more optimized healing outcomes.

Participants will:

  • Receive ACL reconstructive surgery as normal
  • One-half of the participants will receive stem cells at the repair site as the test group
  • All participants will have 3, 6, 9, 12, 18, and 24 month followups to chart their recovery progress Thus, the outcomes of the group receiving stem cell injections will be compared directly with the outcomes of the standard ACL reconstructive care group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to develop a cost-effective, autologous biologic augmentation technique for ACL reconstruction. The technique involves encasing MSCs harvested from the patient's ACL stump tissue with the GraftNet device in a porous bovine collagen matrix carrier around the ACL autograft. This study is key to determining a reproducible and effective autologous biologic augmentation technique that can be utilized at the point-of-care during ACL reconstruction surgery.

FTA results as well as measurements from MRI evaluation will be recorded and utilized to quantify the healing and ACL graft maturation processes. MRI evaluation will be performed in accordance with accepted ACL imaging protocols. This data will then be compared to FTA results and MRI evaluation from patients who did not undergo the bioaugmentation technique for ACL reconstruction.

Study design will be a prospective, blinded randomized, single center trial. Patients at the Andrews Institute who meet the inclusion criteria will have the study explained in detail and informed consent will be obtained as outlined below. Fifty patients will be blinded, randomized, and undergo a Bone-Patellar Tendon-Bone (BTB) ACL reconstruction surgery. Twenty-Five randomized patients will receive standard of care (SOC) BTB ACL reconstruction surgery. Twenty-Five randomized patients will receive BTB ACL reconstruction surgery augmented with the patient's ACL stump tissue harvested with the GraftNet device and a porous bovine collagen matrix carrier around the ACL autograft.

At each follow up visit after ACL reconstruction, patient reported outcome measures (PROMs) will be collected by the research team to assist in assessing the overall health and rehabilitation of each participant. The following patient reported outcomes will be collected in written or electronic format after informed consent has been obtained from each participant:Tampa Scale of Kinesiophobia, International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), Patient Reported Outcome Measurements Information System (PROMIS), Single Assessment Numeric Evaluation (SANE), and Magnetic Resonance Imaging (MRI).

Study Type

Interventional

Enrollment (Anticipated)

50

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
        • Recruiting
        • Andrews Research and Education Foundation

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

14 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between the ages of 14 and 50 who are scheduled to have ACL reconstruction by one of the investigating physicians

Exclusion Criteria:

  • Patients requiring ACL and posterior cruciate ligament combined surgery
  • Patients with a history of an autoimmune disease, diabetes, a blood/clotting disorder
  • History of previous surgery on the injured knee
  • Patients outside of the acceptable age range of this study

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ACL reconstruction utilizing stump-derived mesenchymal stem cells
This is the test group of this study. These participants will receive the augmented ACL reconstruction treatment involving extraction and injection of mesenchymal stem cells. Stem cell tissue will be harvested from each participant using the GraftNet device intraoperatively. During the intra-articular preparation phase of the reconstruction, the stem cell tissue will be applied to the ACL graft using a bovine collagen matrix.
Procedure: ACL reconstruction
Orthopedic surgical operation in which a ruptured anterior cruciate ligament is repaired and reattached to the muscle connection points with a "graft", a fashioned ligament that is meant to serve as a replacement for the ruptured muscle tissue.
Procedure: Mesenchymal stem cell implantation
Stem cells are to be extracted from tissue at the stump of the ACL attachment point and inserted on the graft in the hopes of improving healing response
OTHER: Standard of care ACL reconstructive surgery
This is the control group of this study. These participants will receive standard ACL reconstructive surgery without any augmentations.
Procedure: ACL reconstruction
Orthopedic surgical operation in which a ruptured anterior cruciate ligament is repaired and reattached to the muscle connection points with a "graft", a fashioned ligament that is meant to serve as a replacement for the ruptured muscle tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing functional movement using Functional Testing Algorithm
Time Frame: 3 months post-operative
Battery of tests used to determine the participant's capability of movement during the post-op recovery process; provides physical functional evidence of biomechanical recovery
3 months post-operative
Assessing functional movement using Functional Testing Algorithm
Time Frame: 6 months post-operative
Battery of tests used to determine the participant's capability of movement during the post-op recovery process; provides physical functional evidence of biomechanical recovery
6 months post-operative
Assessing functional movement using Functional Testing Algorithm
Time Frame: 9 months post-operative
Battery of tests used to determine the participant's capability of movement during the post-op recovery process; provides physical functional evidence of biomechanical recovery
9 months post-operative
Assessing functional movement using Functional Testing Algorithm
Time Frame: 12 months post-operative
Battery of tests used to determine the participant's capability of movement during the post-op recovery process; provides physical functional evidence of biomechanical recovery
12 months post-operative
Assessing functional movement using Functional Testing Algorithm
Time Frame: 18 months post-operative
Battery of tests used to determine the participant's capability of movement during the post-op recovery process; provides physical functional evidence of biomechanical recovery
18 months post-operative
Assessing functional movement using Functional Testing Algorithm
Time Frame: 24 months post-operative
Battery of tests used to determine the participant's capability of movement during the post-op recovery process; provides physical functional evidence of biomechanical recovery
24 months post-operative

Collaborators and Investigators

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

Sponsor

Andrews Research & Education Foundation

Collaborators

Florida

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)

August 16, 2022

Primary Completion (ANTICIPATED)

August 16, 2023

Study Completion (ANTICIPATED)

August 16, 2023

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (ACTUAL)

October 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioACL2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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