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

NCT06328166 | Completed DMC

• 1 other identifier: rFGF-1 for CTS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carpal Tunnel Syndrome; recombinant human fibroblast growth factor 1

Outcome Measures

Primary Outcomes (1)

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

  Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.

  Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.

Secondary Outcomes (3)

• Change from baseline of pain on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.

  Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.

• Change from baseline of cross-sectional area of the median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.

  Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.

• Change from baseline of conduction velocity, latency of median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month.

  Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.

Study Arms (2)

recombinant human fibroblast growth factor 1 (ES135)

EXPERIMENTAL

Ultrasound-guided injection with recombinant human fibroblast growth factor 1 (ES135) between carpal tunnel and median nerve.

Procedure: Sono-guided injection with ES135

normal saline

PLACEBO COMPARATOR

Ultrasound-guided injection with normal saline between carpal tunnel and median nerve.

Procedure: Sono-guided injection with placebo

Interventions

Sono-guided injection with ES135 PROCEDURE

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

recombinant human fibroblast growth factor 1 (ES135)

Sono-guided injection with placebo PROCEDURE

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

normal saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-80 year-old.
• Diagnosis was confirmed by using an electrophysiological study
• CTS symptoms for more than 3 months.

You may not qualify if:

• Severe CTS
• Allergy to ES135
• Pregnancy
• Inflammation status
• Cervical radiculopathy
• Polyneuropathy, brachial plexopathy
• Thoracic outlet syndrome
• Previously undergone wrist surgery or steroid/platelet-rich plasma injection for CTS within 12 months

Sponsors & Collaborators

• Tri-Service General Hospital: lead
• Eusol Biotech Co., Ltd.: collaborator

Study Sites (1)

No. 325, Sec. 2, Chenggong Rd., Neihu Dist.

Taipei, 114, Taiwan

Location

Related Publications (6)

• Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.

  PMID: 28778254 BACKGROUND

• Javerzat S, Auguste P, Bikfalvi A. The role of fibroblast growth factors in vascular development. Trends Mol Med. 2002 Oct;8(10):483-9. doi: 10.1016/s1471-4914(02)02394-8.

  PMID: 12383771 BACKGROUND

• Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Huang GS, Chen LC. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial. Sci Rep. 2017 Dec;7(1):94. doi: 10.1038/s41598-017-00224-6. Epub 2017 Mar 7.

  PMID: 28273894 BACKGROUND

• Wu JC, Huang WC, Huang MC, Tsai YA, Chen YC, Shih YH, Cheng H. A novel strategy for repairing preganglionic cervical root avulsion in brachial plexus injury by sural nerve grafting. J Neurosurg. 2009 Apr;110(4):775-85. doi: 10.3171/2008.8.JNS08328.

  PMID: 19119881 BACKGROUND

• Teng YD, Mocchetti I, Wrathall JR. Basic and acidic fibroblast growth factors protect spinal motor neurones in vivo after experimental spinal cord injury. Eur J Neurosci. 1998 Feb;10(2):798-802. doi: 10.1046/j.1460-9568.1998.00100.x.

  PMID: 9749747 BACKGROUND

• Wu JC, Huang WC, Chen YC, Tu TH, Tsai YA, Huang SF, Huang HC, Cheng H. Acidic fibroblast growth factor for repair of human spinal cord injury: a clinical trial. J Neurosurg Spine. 2011 Sep;15(3):216-27. doi: 10.3171/2011.4.SPINE10404. Epub 2011 Jun 10.

  PMID: 21663406 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Yung-Tsan Wu, MD

  Tri-Service General Hospital, School of Medicine, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

• Yu Chi Su, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician and lecturer of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: March 25, 2024
• Study Start: March 22, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)