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The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome

NCT06328166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-10

No results posted yet for this study

Summary

Carpal tunnel syndrome (CTS) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. In recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. Human fibroblast growth factor 1 is a single-chain protein , which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. ES135 is a recombinant human fibroblast growth factor 1 (rhFGF1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. Several studies have shown that significant improvement of Functional Independence Measure, motor and sensory function of spinal cord injury patients after ES135 treatment. One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy. According to above studies, the investigators hypothesized that ES135 may have benefits to CTS patients. Hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS.

Conditions

  • Carpal Tunnel Syndrome

Interventions

PROCEDURE

Sono-guided injection with ES135

Sono-guided injection with ES135 between carpal tunnel and median nerve

PROCEDURE

Sono-guided injection with placebo

Sono-guided injection with placebo between carpal tunnel and median nerve

Sponsors & Collaborators

  • Eusol Biotech Co., Ltd.

    collaborator INDUSTRY

  • Tri-Service General Hospital

    lead OTHER

Principal Investigators

  • Yung-Tsan Wu, MD · Tri-Service General Hospital, School of Medicine, National Defense Medical Center

  • Yu Chi Su, MD · Tri-Service General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-22
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06328166 on ClinicalTrials.gov