ACL InjurySecretome ACLNCT07723625
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
A study testing Secretome in people with ACL Injury and ACL Tear, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- ACL Injury, ACL Tear
- What is being tested?
- Secretome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Nov 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Prof. dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Bali, 80113
About this study
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
- Being tested
- Secretome, Placebo
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretomeBiological
Also called UC-MSCs-derived Secretome, Mesenchymal Stem Cells-derived Secretome
A single intraoperative intralesional injection of 1.5 mL concentrated mesenchymal stem cell (MSC)-derived secretome
PlaceboBiological
Normal Saline Placebo
| Study group | Role | What they receive |
|---|---|---|
| Secretome | Experimental | ACL Reconstruction + Secretome Injection Receives: Biological: Secretome |
| Normal Saline | Placebo comparator | ACL Reconstruction + Placebo Injection Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (preoperative) and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start14 Nov 2025
- Primary completion27 Jan 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by PT. Prodia Stem Cell IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723625
- Sponsor's protocol ID
- CT/ACL/02/2026
- Acronym
- Secretome ACL
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07723625
- Acronym / sponsor ID
- Secretome ACL / CT/ACL/02/2026
- Conditions
- ACL Injury, ACL Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Collaborators
- RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secretome | Experimental | Biological: SecretomeACL Reconstruction + Secretome Injection |
| Normal Saline | Placebo comparator | Biological: PlaceboACL Reconstruction + Placebo Injection |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecretomeAlso: UC-MSCs-derived Secretome, Mesenchymal Stem Cells-derived SecretomeA single intraoperative intralesional injection of 1.5 mL concentrated mesenchymal stem cell (MSC)-derived secretome | Biological | Secretome |
| PlaceboNormal Saline Placebo | Biological | Normal Saline |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secretome in people with ACL Injury and ACL Tear, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score (time frame: Baseline (preoperative) and 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.