Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of Six-Month Functional Outcomes Following Anterior Cruciate Ligament (ACL) Reconstruction Using Peroneus Longus Tendon Grafts With Adjunctive Secretome Injection Versus Without Secretome Injection
Sponsor: PT. Prodia Stem Cell Indonesia
Summary
Anterior cruciate ligament (ACL) reconstruction is commonly performed to restore knee stability after ACL injury; however, graft healing remains a critical determinant of successful outcomes. This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of adjunctive MSC-derived secretome injection administered to the graft during arthroscopic single-bundle ACL reconstruction using a peroneus longus tendon autograft. Twenty-four participants were randomized to receive either secretome injection or placebo. Functional outcomes were assessed using the IKDC Subjective Knee Evaluation Form and the Tegner-Lysholm Knee Scoring Scale before surgery and at six months postoperatively. The study evaluated whether adjunctive secretome injection could improve functional recovery compared with placebo while monitoring treatment safety.
Key Details
Gender
All
Age Range
20 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-11-14
Completion Date
2026-07-01
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
Secretome
A single intraoperative intralesional injection of 1.5 mL concentrated mesenchymal stem cell (MSC)-derived secretome
Placebo
Normal Saline Placebo
Locations (1)
Prof. dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Bali, Indonesia