Clinical Trial

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

Study acronym: Secretome ACL
Completed
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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.
Trial Details
NCT Number NCT07723625
Lead Sponsor PT. Prodia Stem Cell Indonesia
Collaborators: RSUP Prof. Dr. I.G.N.G. Ngoerahal
Conditions ACL Injury, ACL Tear
Enrollment 24 participants
Start Date 2025-11-14
Primary Completion 2026-01-27 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-23