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 (Secretome ACL)

July 19, 2026 updated by: PT. Prodia Stem Cell Indonesia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia, 80113
        • Prof. dr. I.G.N.G. Ngoerah General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Complete anterior cruciate ligament (ACL) rupture confirmed by magnetic resonance imaging (MRI).
  • Positive pivot-shift test.
  • Positive Lachman test.
  • Positive anterior drawer test.
  • Scheduled to undergo arthroscopic ACL reconstruction using a peroneus longus tendon autograft.
  • Surgery performed by the same surgical team.
  • Age 18 to <40 years.

Exclusion Criteria:

  • Partial ACL tear.
  • History of previous ACL reconstruction surgery.
  • Multi-ligament knee injury involving more than two ligaments.
  • Generalized ligamentous laxity confirmed using the Beighton Hypermobility Score.
  • Unwilling or unable to comply with the scheduled follow-up through 6 months postoperatively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secretome
ACL Reconstruction + Secretome Injection
Biological: Secretome
A single intraoperative intralesional injection of 1.5 mL concentrated mesenchymal stem cell (MSC)-derived secretome
Other Names:
  • UC-MSCs-derived Secretome
  • Mesenchymal Stem Cells-derived Secretome
Placebo Comparator: Normal Saline
ACL Reconstruction + Placebo Injection
Biological: Placebo
Normal Saline Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Time Frame: Baseline (preoperative) and 6 months after surgery
The IKDC Subjective Knee Evaluation Form assesses symptoms, knee function, and ability to perform sports activities. Scores range from 0 to 100, with higher scores indicating better knee function.
Baseline (preoperative) and 6 months after surgery
Tegner-Lysholm Knee Scoring Scale
Time Frame: Baseline (preoperative) and 6 months postoperatively.
The Tegner-Lysholm Knee Scoring Scale evaluates knee function, pain, instability, locking, swelling, stair climbing, squatting, limp, and need for support. Scores range from 0 to 100, with higher scores indicating better functional outcomes.
Baseline (preoperative) and 6 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Prodia Stem Cell Indonesia

Collaborators

RS Prof. Dr. I.G.N.G Ngoerah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2025

Primary Completion (Actual)

January 27, 2026

Study Completion (Actual)

July 1, 2026

Study Registration Dates

First Submitted

July 19, 2026

First Submitted That Met QC Criteria

July 19, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 19, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/ACL/02/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because participant consent for public data sharing was not obtained, and institutional policies require that individual-level clinical data remain confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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