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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
ACL Tear
Intervention / Treatment

-

Contacts and Locations

Gulf Breeze

Andrews Research and Education Foundation, Gulf Breeze, Florida, United States, 32561

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

14 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Andrews Research & Education Foundation,

Adam Anz, MD, PRINCIPAL_INVESTIGATOR, Orthopedic Surgeon

Study Record Dates

2023-08-16