Recruiting

Mesenchymal Stem Cells & Collagen Matrix

Sponsor:

Andrews Research & Education Foundation

Code:

NCT05582226

Conditions

ACL Tear

Eligibility Criteria

Sex: All

Age: 14 - 50

Healthy Volunteers: Not accepted

Interventions

ACL reconstruction

Mesenchymal stem cell implantation

Study Details

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.

Conditions

ACL Tear

Study ID

NCT05582226

Start date

Aug 16, 2022

Status verified date

Feb, 2023

Completion date

Aug 16, 2023

Anticipated

Primary completion date

Aug 16, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Assessing functional movement using Functional Testing Algorithm [ Time Frame: 3 months post-operative ]
  • Assessing functional movement using Functional Testing Algorithm [ Time Frame: 6 months post-operative ]
  • Assessing functional movement using Functional Testing Algorithm [ Time Frame: 9 months post-operative ]
  • Assessing functional movement using Functional Testing Algorithm [ Time Frame: 12 months post-operative ]
  • Assessing functional movement using Functional Testing Algorithm [ Time Frame: 18 months post-operative ]
  • Assessing functional movement using Functional Testing Algorithm [ Time Frame: 24 months post-operative ]

Central Contacts and Locations

Central contacts

Jessi Truett, MA, BCBA

8509168570jessica.truett@andrewsref.org

Matt Farmer, BS

8509168487matt.farmer@andrewsref.org

Locations

Andrews Research and Education Foundation

Recruiting

Gulf Breeze, Florida, United States, 32561

Contacts

Jessi Truett, MA, BCBA

850-916-8570jessica.truett@andrewsref.org

Joshua Cook, BS

8509168590joshua.cook@andrewsref.org

More Information

Sponsor

Andrews Research & Education Foundation

Last update posted

Feb 10, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrews Research & Education Foundation on 2023-02-10.