NCT07723625

Brief 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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 19, 2026

Last Update Submit

July 19, 2026

Conditions

ACL InjuryACL Tear

Outcome Measures

Primary Outcomes (2)

  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score

    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

    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.

Study Arms (2)

Secretome

EXPERIMENTAL

ACL Reconstruction + Secretome Injection

Biological: Secretome

Normal Saline

PLACEBO COMPARATOR

ACL Reconstruction + Placebo Injection

Biological: Placebo

Interventions

SecretomeBIOLOGICAL

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

Also known as: UC-MSCs-derived Secretome, Mesenchymal Stem Cells-derived Secretome
Secretome
PlaceboBIOLOGICAL

Normal Saline Placebo

Normal Saline

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Denpasar, Bali, 80113, Indonesia

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Secretome

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

MetabolomeMetabolism

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2026

First Posted

July 23, 2026

Study Start

November 14, 2025

Primary Completion

January 27, 2026

Study Completion

July 1, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

ID(1)