RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-08-16
Study Completion:2023-08-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05582226

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.

Ages Eligible for Study:14 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients between the ages of 14 and 50 who are scheduled to have ACL reconstruction by one of the investigating physicians
  1. * Patients requiring ACL and posterior cruciate ligament combined surgery
  2. * Patients with a history of an autoimmune disease, diabetes, a blood/clotting disorder
  3. * History of previous surgery on the injured knee
  4. * Patients outside of the acceptable age range of this study

Contacts and Locations

Study Contact

Jessi Truett, MA, BCBA
CONTACT
8509168570
jessica.truett@andrewsref.org
Matt Farmer, BS
CONTACT
8509168487
matt.farmer@andrewsref.org

Principal Investigator

Adam Anz, MD
PRINCIPAL_INVESTIGATOR
Orthopedic Surgeon

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Andrews Research & Education Foundation

  • Adam Anz, MD, PRINCIPAL_INVESTIGATOR, Orthopedic Surgeon

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 Registration Dates

Study Start Date2022-08-16
Study Completion Date2023-08-16

Study Record Updates

Study Start Date2022-08-16
Study Completion Date2023-08-16

Terms related to this study

Additional Relevant MeSH Terms

  • ACL Tear