Unique ID issued by UMIN | UMIN000039992 |
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Receipt number | R000045597 |
Scientific Title | Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency |
Date of disclosure of the study information | 2020/03/31 |
Last modified on | 2023/10/25 16:29:54 |
Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Japan |
limbal stem-cell deficiency(LSCD)
Ophthalmology |
Others
NO
The purpose of this study is to evaluate long-term safety and efficacy in patients with LSCD to whom cultivated autologous oral mucosal epithelial cell sheet (COMET01) have been transplanted in the clinical study (protocol No. OUH-COMET01).
Safety,Efficacy
1) LSCD staging for 104 weeks after COMET01 transplantation
Efficacy
2) LSCD staging after COMET01 transplantation
3) Subjective symptom
4) Visual acuity
5) QOL
6) Corneal opacity
7) Corneal neovascularization
8) Symblepharon
9) Contributing to the regeneration corneal epithelium in patients with additional therapy
10) LSCD staging, subjective symptom, visual acuity, corneal opacity, corneal neovascularization, and symblepharon of fellow eye
* This study makes no distinction between primary and secondary efficacy endpoints
Safety
1) Number and rate of adverse events and product-related adverse events
2) Number and rate of significant product-related adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Observation of efficacy and safety of COMET01 transplant patients after 78 and 104 weeks
Not applicable |
Not applicable |
Male and Female
1) Patients enrolled in the COMET01 study and transplanted with investigational products
1) Patients planning to participate in other clinical trials during the study participation
2) Patients who desire pregnancy during clinical studies
3) Patients determined to be inappropriate by physicians
6
1st name | Shigeaki |
Middle name | |
Last name | Hayashi |
Japan Tissue Engineering Co., Ltd.
Clinical Development Dept.
443-0022
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
0533-66-2020
shigeaki_hayashi@jpte.co.jp
1st name | Masami |
Middle name | |
Last name | Suzuki |
Japan Tissue Engineering Co., Ltd.
Clinical Development Dept.
443-0022
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
0533-66-2020
masami_suzuki@jpte.co.jp
Japan Tissue Engineering Co., Ltd.
None
Self funding
Institutional Review Board of Osaka University Hospital
2-15 Yamadaoka, Suita, Osaka 565-0871
06-6210-8290
Jim-chikenn@hp-crc.med.osaka-u.sc.jp
NO
2020 | Year | 03 | Month | 31 | Day |
Unpublished
6
Delay expected |
Because data is being prepared.
Completed
2016 | Year | 09 | Month | 08 | Day |
2017 | Year | 01 | Month | 23 | Day |
2016 | Year | 11 | Month | 18 | Day |
2018 | Year | 08 | Month | 17 | Day |
2019 | Year | 07 | Month | 31 | Day |
This study is long-term follow-up clinical trial of COMET01 study(UMIN000018662)
2020 | Year | 03 | Month | 31 | Day |
2023 | Year | 10 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045597
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