Complete Title: Phase I-II study for therapeutic efficacy of local recombinant human local insulin like growth factor 1 treatment via biodegradable gelatin hydrogels for acute sensorineural hearing loss
We enrolled planned 25 patients and stopped recruiting.
The result of this clinical trial was published on BMC Medicine.
Topical insulin-like growth factor 1 treatment using gelatin hydrogels for glucocorticoid-resistant sudden sensorineural hearing loss: a prospective clinical trial
Takayuki Nakagawa , Tatsunori Sakamoto , Harukazu Hiraumi , Yayoi S Kikkawa , Norio Yamamoto , Kiyomi Hamaguchi , Kazuya Ono , Masaya Yamamoto , Yasuhiko Tabata , Satoshi Teramukai , Shiro Tanaka , Harue Tada , Rie Onodera , Atsushi Yonezawa , Ken-ichi Inui and Juichi Ito
Published:25 November 2010
IGF-1/Gelatin Hydrogel for Acute Sensorineural Hearing Loss
IGF-1 (insulin-like growth fator) is a multifunctional peptide that plays essential roles in regulation of growth and development in various parts of the body, including the inner ear1. IGF-1 is also known to be a neuroprotective agent2 .
Recombinant human IGF-1 (rhIGF-1) has already been approved for clinical use in the treatment of juvenile growth failure or a certain type of diabetes mellitus.
Gelatin hydrogel is a biodegradable material developed by Dr. Tabata (Institute for Frontier Medical Sciences, Kyoto University)3. Drugs immersed in this material are slowly released when the hydrogel is degraded by hydrolysis (Figure 1).
We have been investigating this IGF-1/hydrogel treatment for acute sensorineural hearing loss. A small amount of IGF-1 immersed gel is placed on the round window membrane through a small hole made surgically on the tympanic membrane (Figure 2). IGF-1 is slowly released from the gel and infiltrate into the cochlea (sound sensing organ) and works there. We developed this treatment in 20054 and we were able to show its hearing protective effect on animal studies5,6 .
Sudden sensorineural hearing loss is a condition that one loses hearing in one ear within three days of at least 30 decibels (dB) over at least three test frequencies. Incidence is reported to be between 5-20 cases per 100,000 population per year7. Some patients do experience spontaneous recovery, but the rate is low. Systemic steroids are the most widely used treatment for sudden sensorineural hearing loss. Unfortunately, about 20% of patients do not respond to steroids8.
In January 2008, we initiated a clinical study using this IGF-1/hydrogel system for acute sensorineural hearing loss patiants that steroids were not effective. The aim of this study is to examine the safety and Figure 2efficacy of local recombinant human IGF1 application using biodegradable gelatin hydrogels. Eligible patients must be
- 1) diagnosed as acute sensorineural hearing loss
- 2) within 29 days after the onset of hearing loss
- 3) after systemic steroid therapy, which was not effective
- 4) age 20 years old or over
- 5) able to come to outpatient clinic of Kyoto University Hospital, and
- 6) can give informed consent to participate in this trial.
Detailed patient criteria for this study can be found here (search UMIN trial number: UMIN000000936). Patient information and professional information are also available (both in Japanese). For more information, e-mail tomail address.
Questions and Answers
- Q1. Do I have to go to Kyoto University Hospital to receive this treatment?
- A1.Yes. You have to register before the treatment (as an outpatient). After the treatment you have to continue to stay in the hospital for 4 days. Afterward you have to visit the hospital at least 5 times within the following 24 weeks. Transportation is not provided.
- Q2. I had sudden hearing loss 2 months ago. Can I enroll in the study?
- A2.No. This is a clinical trial monitored closely by the Medical Ethics Committee of Kyoto University. In order to be eligible for this treatment, patients must fulfill all the conditions above. We are sorry we cannot provide this treatment outside the defined criteria.
- Varela-Nieto I, Morales-Garcia JA, Vigil Pet al. Trophic effects of insulin-like growth factor-I
(IGF-I) in the inner ear. Hear Res 2004;196:19-25.
- Linseman DA, Phelps RA, Bouchard RJet al. Insulin-like growth factor-I blocks Bcl-2 interacting mediator of cell death (Bim) induction and intrinsic death signaling in cerebellar granule neurons. J Neurosci 2002;22:9287-9297.
- Tabata Y, Yamada K, Miyamoto Set al. Bone regeneration by basic fibroblast growth factor complexed with biodegradable hydrogels. Biomaterials 1998;19:807-815.
- Endo T, Nakagawa T, Kita Tet al. Novel strategy for treatment of inner ears using a biodegradable gel. Laryngoscope 2005;115:2016-2020.
- Iwai K, Nakagawa T, Endo Tet al. Cochlear protection by local insulin-like growth factor-1 application using biodegradable hydrogel. Laryngoscope 2006;116:529-533.
- Lee KY, Nakagawa T, Okano Tet al. Novel therapy for hearing loss: delivery of insulin-like growth factor 1 to the cochlea using gelatin hydrogel. Otol Neurotol 2007;28:976-981.
- Byl FM. Seventy-six cases of presumed sudden hearing loss occurring in 1973: prognosis and incidence. Laryngoscope 1977;87:817-825.
- Wilson WR, Byl FM, Laird N. The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Arch Otolaryngol 1980;106:772-776.
2008.4.22 YSK, TS, TN
Last update： 2013-05-01 14:30