Augmentation of Anterior Cruciate Ligament Reconstruction Using Mesenchymal Stem Cells and Collagen Matrix Carrier
Status unconfirmed · Not applicable
Conditions studied: ACL Tear
In brief
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.
Key facts
- Study ID
- NCT05582226
- Run by
- Andrews Research & Education Foundation
- People needed
- 50
- Starts
- 2022-08-16
- Expected to finish
- 2023-08-16
- Last updated by the study team
- 2023-02-10
Who can join
Age: 14 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients between the ages of 14 and 50 who are scheduled to have ACL reconstruction by one of the investigating physicians
You may not qualify if…
- 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
Where it is running
- Andrews Research and Education Foundation — Gulf Breeze, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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