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COMPLETED
NCT07723625
NA

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Secretome

A single intraoperative intralesional injection of 1.5 mL concentrated mesenchymal stem cell (MSC)-derived secretome

BIOLOGICAL

Placebo

Normal Saline Placebo

Locations (1)

Prof. dr. I.G.N.G. Ngoerah General Hospital

Denpasar, Bali, Indonesia