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OpenTrials
Completed

NCT Number: NCT07723625

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

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.

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Key information

Conditions

ACL Injury ACL Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Denpasar, Bali, 80113, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secretome

Biological

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

Biological

Normal Saline Placebo

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Collaborators

  • RS Prof. Dr. I.G.N.G Ngoerah

Registry information

Acronym: Secretome ACL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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