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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

NCT07723625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • ACL Injury
  • ACL Tear

Interventions

BIOLOGICAL

Secretome

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

BIOLOGICAL

Placebo

Normal Saline Placebo

Sponsors & Collaborators

  • RSUP Prof. Dr. I.G.N.G. Ngoerahal

    collaborator OTHER

  • PT. Prodia Stem Cell Indonesia

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2026-01-27
Completion
2026-07-01

Countries

  • Indonesia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723625 on ClinicalTrials.gov