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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Sono-guided injection with ES135; Procedure: Sono-guided injection with placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Chi Su, MD; Phone Number: +886287923311; Email: vickysu0110@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: recombinant human fibroblast growth factor 1 (ES135); Ultrasound-guided injection with recombinant human fibroblast growth factor 1 (ES135) between carpal tunnel and median nerve.	Procedure: Sono-guided injection with ES135; Sono-guided injection with ES135 between carpal tunnel and median nerve
Placebo Comparator: normal saline; Ultrasound-guided injection with normal saline between carpal tunnel and median nerve.	Procedure: Sono-guided injection with placebo; Sono-guided injection with placebo between carpal tunnel and median nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of pain on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.	Digital pain severity or paresthesia/dysesthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.	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.	Using the musculoskeletal sonogram to measure the cross-sectional area (mm2) of the median nerve before treatment and multiple time frame after treatment	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.	electrophysiological study of the median nerve: Distal motor latency (ms)、Sensory nerve conduction velocity (m/s) before treatment and multiple time frame after treatment	Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Collaborators: Eusol Biotech Co., Ltd.
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 22, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; recombinant human fibroblast growth factor 1
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: rFGF-1 for CTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No