Clinical trial NCT06328166: The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome
Official title: The Effect and Safety of Recombinant Human Fibroblast Growth Factor-1 for Patient with Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
recombinant human fibroblast growth factor 1
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
Collaborators: name: Eusol Biotech Co., Ltd.
First posted: 2024-03-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.
timeFrame: Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.
Secondary outcomes:
measure: Change from baseline of pain on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.
timeFrame: Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.
measure: Change from baseline of cross-sectional area of the median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.
timeFrame: Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.
measure: Change from baseline of conduction velocity, latency of median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month.
timeFrame: Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: No. 325, Sec. 2, Chenggong Rd., Neihu Dist.
Study officials:
affiliation: Tri-Service General Hospital, School of Medicine, National Defense Medical Center
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tri-Service General Hospital
name: Yu Chi Su, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.