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

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

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.