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

NCT ID: NCT06328166

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-22
• Study Completion Date: 2025-05-30

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.

Detailed Description

Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to ES135 or Placebo groups. With ultrasound guidance, injection with ES135 or Placebo was performed between median nerve and transcarpal ligament. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies and cross-sectional area of the median nerve. The assessment is performed prior injection and at 1, 2, 3, 4 and 6 months post-injection.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

recombinant human fibroblast growth factor 1 (ES135)

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

Group Type: EXPERIMENTAL

Sono-guided injection with ES135

Intervention Type: PROCEDURE

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

normal saline

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

Group Type: PLACEBO_COMPARATOR

Sono-guided injection with placebo

Intervention Type: PROCEDURE

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

Interventions

Sono-guided injection with ES135

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

Intervention Type: PROCEDURE

Sono-guided injection with placebo

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eusol Biotech Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-CHI Su

Attending Physician and lecturer of Department of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yung-Tsan Wu, MD

Role: PRINCIPAL_INVESTIGATOR

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

Yu Chi Su, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

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

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 28778254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12383771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28273894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19119881 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9749747 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21663406 (View on PubMed)

Other Identifiers

rFGF-1 for CTS

Identifier Type: -

Identifier Source: org_study_id