Carpal Tunnel Syndrome (CTS)Early Phase 1Secretome CTSNCT07723313
Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
A Early Phase 1 study testing Secretome, amniotic membrane and Standard surgery in people with Carpal Tunnel Syndrome (CTS), run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial summary
Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Secretome, amniotic membrane and Standard surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Dec 2025to 15 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosed with moderate-to-severe Carpal Tunnel Syndrome (CTS) based on electromyography (EMG) according to the Bland classification.
- Persistent CTS symptoms that have not improved with conservative treatment.
- Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Previous carpal tunnel release surgery on the affected wrist.
- History of wrist trauma or previous wrist surgery.
- Presence of comorbidities that may affect nerve healing or study outcomes, including diabetes mellitus, hypertension, or metabolic disorders.
- Symptoms resembling CTS are attributable to other conditions, such as cervical spine or cervical nerve disorders (e.g., cervical radiculopathy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Prof. dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Bali, 80113
Shianita Limena, Medical Doctor, +62 811-910-624, shianita.limena@gmail.com
Made Bramantya Karna, Medical Doctor
About this study
Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function. This study is a randomized controlled trial with a pre- and post-intervention experimental design to evaluate the effectiveness of adjunctive amniotic membrane combined with secretome in patients with moderate-to-severe CTS undergoing carpal tunnel release surgery. Participants will be randomly assigned to receive either standard surgical treatment alone or surgery with the addition of amniotic membrane and secretome. Clinical and electrophysiological outcomes will be evaluated before surgery and at 3 weeks after the intervention using the Boston Carpal Tunnel Questionnaire (BCTQ) and electromyography (EMG) to assess symptom improvement, functional recovery, and median nerve regeneration.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Secretome, amniotic membrane, Standard surgery
- Medical subject headings
- Carpal Tunnel Syndrome
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
Participants undergoing carpal tunnel release surgery will receive a 10 mm × 10 mm amniotic membrane soaked in 1.5 mL of secretome solution for 1 minute before application to the median nerve at the surgical site.
amniotic membraneOther
Participants undergoing carpal tunnel release surgery will receive a 10 mm × 10 mm amniotic membrane applied to the median nerve at the surgical site without secretome.
Standard surgeryProcedure or surgery
Participants will undergo standard carpal tunnel release surgery without the addition of amniotic membrane or secretome.
| Study group | Role | What they receive |
|---|---|---|
| Amnion Membrane + Secretome | Active comparator | Not described Receives: Biological: Secretome |
| Amniotic Membrane | Active comparator | Not described Receives: Other: amniotic membrane |
| Standard Surgery | Placebo comparator | Not described Receives: Procedure: Standard surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire (BCTQ) score
The Boston Carpal Tunnel Questionnaire (BCTQ), consisting of the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), will be used to evaluate changes in symptom severity and hand function from baseline to 3 weeks after surgery.
Measured: Baseline and 3 weeks postoperatively
Electromyography (EMG)
Electromyography (EMG) will be performed to assess changes in median nerve electrophysiological function, including nerve conduction parameters, from baseline to 3 weeks after surgery.
Measured: Baseline and 3 weeks 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 start15 Dec 2025
- Primary completion15 Mar 2026
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
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
- NCT07723313
- Sponsor's protocol ID
- CT/CTS/01/2026
- Acronym
- Secretome CTS
- Status last verified
- Jul 2026
- First submitted
- 20 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
- Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
- ClinicalTrials.gov ID
- NCT07723313
- Acronym / sponsor ID
- Secretome CTS / CT/CTS/01/2026
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Collaborators
- RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Aug 2026 (estimated)
- 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.
Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function. This study is a randomized controlled trial with a pre- and post-intervention experimental design to evaluate the effectiveness of adjunctive amniotic membrane combined with secretome in patients with moderate-to-severe CTS undergoing carpal tunnel release surgery. Participants will be randomly assigned to receive either standard surgical treatment alone or surgery with the addition of amniotic membrane and secretome. Clinical and electrophysiological outcomes will be evaluated before surgery and at 3 weeks after the intervention using the Boston Carpal Tunnel Questionnaire (BCTQ) and electromyography (EMG) to assess symptom improvement, functional recovery, and median nerve regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amnion Membrane + Secretome | Active comparator | Biological: Secretome |
| Amniotic Membrane | Active comparator | Other: amniotic membrane |
| Standard Surgery | Placebo comparator | Procedure: Standard surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Diagnosed with moderate-to-severe Carpal Tunnel Syndrome (CTS) based on electromyography (EMG) according to the Bland classification.
- Persistent CTS symptoms that have not improved with conservative treatment.
- Willing and able to provide written informed consent and comply with study procedures.
Key exclusion criteria (4 listed)
- Previous carpal tunnel release surgery on the affected wrist.
- History of wrist trauma or previous wrist surgery.
- Presence of comorbidities that may affect nerve healing or study outcomes, including diabetes mellitus, hypertension, or metabolic disorders.
- Symptoms resembling CTS are attributable to other conditions, such as cervical spine or cervical nerve disorders (e.g., cervical radiculopathy).
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 SecretomeParticipants undergoing carpal tunnel release surgery will receive a 10 mm × 10 mm amniotic membrane soaked in 1.5 mL of secretome solution for 1 minute before application to the median nerve at the surgical site. | Biological | Amnion Membrane + Secretome |
| amniotic membraneParticipants undergoing carpal tunnel release surgery will receive a 10 mm × 10 mm amniotic membrane applied to the median nerve at the surgical site without secretome. | Other | Amniotic Membrane |
| Standard surgeryParticipants will undergo standard carpal tunnel release surgery without the addition of amniotic membrane or secretome. | Procedure or surgery | Standard Surgery |
Primary outcome
Boston Carpal Tunnel Questionnaire (BCTQ) score
Time frame: Baseline and 3 weeks postoperatively
The Boston Carpal Tunnel Questionnaire (BCTQ), consisting of the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), will be used to evaluate changes in symptom severity and hand function from baseline to 3 weeks after surgery.
Electromyography (EMG)
Time frame: Baseline and 3 weeks postoperatively
Electromyography (EMG) will be performed to assess changes in median nerve electrophysiological function, including nerve conduction parameters, from baseline to 3 weeks after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Related trials for Carpal Tunnel Syndrome (CTS)
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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.
Prof. dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Secretome, amniotic membrane and Standard surgery in people with Carpal Tunnel Syndrome (CTS), 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 4 inclusion and 4 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: looking for participants now, 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Questionnaire (BCTQ) score (time frame: Baseline and 3 weeks postoperatively). 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; AzTrials last refreshed its copy on 7 Nov 2026.