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

Primary Purpose

ACL Tear

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACL reconstruction
Mesenchymal stem cell implantation
Sponsored by
Andrews Research & Education Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Tear

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andrews Research and Education FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ACL reconstruction utilizing stump-derived mesenchymal stem cells

Standard of care ACL reconstructive surgery

Arm Description

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.

This is the control group of this study. These participants will receive standard ACL reconstructive surgery without any augmentations.

Outcomes

Primary Outcome Measures

Assessing functional movement using Functional Testing Algorithm
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
Assessing functional movement using Functional Testing Algorithm
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
Assessing functional movement using Functional Testing Algorithm
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
Assessing functional movement using Functional Testing Algorithm
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
Assessing functional movement using Functional Testing Algorithm
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
Assessing functional movement using Functional Testing Algorithm
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

Secondary Outcome Measures

Full Information

First Posted
October 6, 2022
Last Updated
February 9, 2023
Sponsor
Andrews Research & Education Foundation
Collaborators
Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05582226
Brief Title
Augmentation of Anterior Cruciate Ligament Reconstruction Using Mesenchymal Stem Cells and Collagen Matrix Carrier
Acronym
BioACL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
August 16, 2023 (Anticipated)
Study Completion Date
August 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andrews Research & Education Foundation
Collaborators
Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized into one of two groups, the first group receiving stump stem cell infusion and the second group receiving standard of care ACL reconstruction
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACL reconstruction utilizing stump-derived mesenchymal stem cells
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care ACL reconstructive surgery
Arm Type
Other
Arm Description
This is the control group of this study. These participants will receive standard ACL reconstructive surgery without any augmentations.
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mesenchymal stem cell implantation
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessing functional movement using Functional Testing Algorithm
Description
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
Time Frame
3 months post-operative
Title
Assessing functional movement using Functional Testing Algorithm
Description
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
Time Frame
6 months post-operative
Title
Assessing functional movement using Functional Testing Algorithm
Description
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
Time Frame
9 months post-operative
Title
Assessing functional movement using Functional Testing Algorithm
Description
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
Time Frame
12 months post-operative
Title
Assessing functional movement using Functional Testing Algorithm
Description
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
Time Frame
18 months post-operative
Title
Assessing functional movement using Functional Testing Algorithm
Description
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
Time Frame
24 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessi Truett, MA, BCBA
Phone
8509168570
Email
jessica.truett@andrewsref.org
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Farmer, BS
Phone
8509168487
Email
matt.farmer@andrewsref.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Anz, MD
Organizational Affiliation
Orthopedic Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andrews Research and Education Foundation
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessi Truett, MA, BCBA
Phone
850-916-8570
Email
jessica.truett@andrewsref.org
First Name & Middle Initial & Last Name & Degree
Joshua Cook, BS
Phone
8509168590
Email
joshua.cook@andrewsref.org

12. IPD Sharing Statement

Plan to Share IPD
No
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Augmentation of Anterior Cruciate Ligament Reconstruction Using Mesenchymal Stem Cells and Collagen Matrix Carrier

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