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

ACL Tear Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582226
• Other study ID #: BioACL2.0
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: August 16, 2023

Study information

• Verified date: February 2023
• Source: Andrews Research & Education Foundation
• Contact: Jessi Truett, MA, BCBA
• Phone: 8509168570
• Email: jessica.truett[@]andrewsref.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Tear
• Anterior Cruciate Ligament Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Andrews Research and Education Foundation	Gulf Breeze	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Andrews Research & Education Foundation	Florida

Country where clinical trial is conducted

United States, 

References & Publications (35)

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Takayama K, Kawakami Y, Mifune Y, Matsumoto T, Tang Y, Cummins JH, Greco N, Kuroda R, Kurosaka M, Wang B, Fu FH, Huard J. The effect of blocking angiogenesis on anterior cruciate ligament healing following stem cell transplantation. Biomaterials. 2015 Aug;60:9-19. doi: 10.1016/j.biomaterials.2015.03.036. Epub 2015 May 14. — View Citation

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months post-operative
Primary	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	6 months post-operative
Primary	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	9 months post-operative
Primary	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	12 months post-operative
Primary	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	18 months post-operative
Primary	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	24 months post-operative