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Facial nerve regeneration surgery using fibroblast growth factor in Bell's palsy and Hunt syndrome

Facial nerve regeneration surgery using fibroblast growth factor in Bell's palsy and Hunt syndrome - Facial nerve regenerating surgery for Bell's palsy and Hunt syndrome

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016334
Enrollment
120
Registered
2015-01-26
Start date
2015-01-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bell&#39

Interventions

In intervention group: Facial nerve regenerating surgery with human recombinant bFGF (Fiblast spray, Kaken Pharmaceutical CO., Tokyo, Japan) via gelatin hydrogel. In control group: Transmastoid co

Sponsors

Department of Otolaryngology Head and Neck Surgery, Ehime University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult severe Bell's palsy and Hunt syndrome patients, who are older than 15 years, complete facial palsy(10 or less yanagihara score), degree of denervation exceeding 90% with ENoG and clinical follow unavailable for more than 12 month

Exclusion criteria

Exclusion criteria: The exclusion criteria are (1) pregnancy, (2) current neoplasms, (3) chronic kidney disease, (4) chronic liver disease, (5) immune-suppression (6) opt out decompression surgery

Design outcomes

Primary

MeasureTime frame
Non-recovery rate at 12 months after disease onset. Recovery is defined as an improvement of the House-Brackmann facial grading score 1-2.—

Secondary

MeasureTime frame
Non-recovery rate at 6 months after disease onset, incidence rate of sequelae at 12 months after disease onset. Postoperative bleeding which needs hemostasis in operating room and audiometric threshold elevation using air conduction pure tone audiometry at 250 Hz, 500 Hz, 1 kHz, 2 kHz, and 4 kHz test frequencies—

Countries

Japan

Contacts

Public ContactTakashi Fujiwara

Ehime University Otolaryngology Head and Neck Surgery

t.fujiwarabi@gmail.com0899605366

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026