An Early Phase 1 interventional study of Secretome and amniotic membrane in Carpal Tunnel Syndrome (CTS), sponsored by PT. Prodia Stem Cell Indonesia. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by PT. Prodia Stem Cell Indonesia · Early Phase 1, Interventional, and Treatment
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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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 444 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →PT. Prodia Stem Cell Indonesia is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Secretome
Other: amniotic membrane
Procedure: Standard surgery
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.
Also known as: UC-MSCs-derived Secretome, Mesenchymal Stem Cells-derived Secretome
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.
Participants will undergo standard carpal tunnel release surgery without the addition of amniotic membrane or secretome.
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.
Time frame: 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.
Time frame: Baseline and 3 weeks postoperatively
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in Mar 2026, 3 months.
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PT. Prodia Stem Cell Indonesia