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The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome - Trial NCT06328166

Access comprehensive clinical trial information for NCT06328166 through Pure Global AI's free database. This phase not specified trial is sponsored by Tri-Service General Hospital and is currently Not yet recruiting. The study focuses on Carpal Tunnel Syndrome. Target enrollment is 28 participants.

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Trial Details
ClinicalTrials.gov โ€ข NCT06328166
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The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome
The Effect and Safety of Recombinant Human Fibroblast Growth Factor-1 for Patient With Carpal Tunnel Syndrome

Study Focus

Carpal Tunnel Syndrome

Sono-guided injection with ES135

Interventional

procedure

Sponsor & Location

Tri-Service General Hospital

Timeline & Enrollment

N/A

Mar 22, 2024

Dec 31, 2024

28 participants

Primary Outcome

Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.

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.

ICD-10 Classifications

Carpal tunnel syndrome
Tarsal tunnel syndrome
Arthrosis of first carpometacarpal joint, unspecified
Arthrosis of first carpometacarpal joint
Other specified disorders of synovium and tendon

Data Source

ClinicalTrials.gov

NCT06328166

Non-Device Trial