UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028366 |
|---|---|
| Receipt number | R000032442 |
| Scientific Title | A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients. |
| Date of disclosure of the study information | 2017/07/25 |
| Last modified on | 2021/05/31 11:35:54 |
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Basic information
Public title
A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients.
Acronym
A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients.
Scientific Title
A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients.
Scientific Title:Acronym
A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients.
Region
| Japan |
Condition
Condition
dystrophic epidermolysis bullosa
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Multi-center, open-clinical trial of human mesenchymal stem cells derived from adipocytes (ALLO-ASC sheet) for the treatment of dystrophic epidermolysis bullosa.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Improvement in size of cutaneous ulcer at 5 weeks after the ISN001 application completion.
Key secondary outcomes
(1)Improvement of cutaneous ulcer size at every visit
(2)Re-epithelization of the lesions treated
(3)Over-all clinical efficacy assessment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
ISN001, the sheet containing allogenic adipose derived mesenchymal stromal cells (1000000/sheet), is applied to the lesion(s) once a week up to 8 times
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients who are diagnosed with dystrophic epidermolysis bullosa according to the immunostaining test:
(2)Patients with cutaneous ulcer size of 10 - 250cm2
(3)Patients with 50% or fewer changes in cutaneous ulcer size during the screening period
Key exclusion criteria
(1)Patients with the following medical histories.
1)Patients who are being suffered from squamous cell carcinoma except more than one year has passed without relapses following surgical operations.
2)Patients with severe allergic reactions such as shock and/or anaphylaxis clinical symptoms
3)Patients with skin hypersensitivities against topically applied medicines.
4)Patients with allergies against xenogeneic proteins
5)Patients with allergies against penicillin, streptomycin and/or amphotericin B.
2) Patients with the following complications.
1) Severe functional failures in the liver, heart and/or lung.
(3)Patients who underwent the following conditions within one year of the day of initiation of this study.
1) Drug abuses
2) Alcohol dependencies
(4)Patients who participated in other clinical trials and/or intervention studies within 4 months (120 days) of the day of initiation of this study.
(5)Patients who are considered not suitable for the study by principal investigator.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Aoyagi |
| Middle name | |
| Last name | Teikichi |
Organization
Ishin Pharmaceutical Co. Ltd.,
Division name
Clinical development department
Zip code
103-0023
Address
2-3-11 Nihonbashi-honcyo, Chuo-ku, Tokyo, Japan.
TEL
03-6262-5243
aoyagi@ishinpharma.co.jp
Public contact
Name of contact person
| 1st name | Kikuta |
| Middle name | |
| Last name | Sadao |
Organization
Ishin Pharmaceutical Co. Ltd.,
Division name
Clinical development department
Zip code
103-0023
Address
2-3-11 Nihonbashi-honcyo, Chuo-ku, Tokyo, Japan.
TEL
03-6262-5243
Homepage URL
kikuta@ishinpharma.co.jp
Sponsor or person
Institute
Ishin Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ishin Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University
Address
Noeth 14 West 5 , kita-ku, Sapporo 060-8638, Japan
Tel
011-706-7061
tiken@med.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
・北海道大学病院（北海道）Hokkaido University Hospital
・東邦大学医療センター大森病院（東京都）Toho University Omori Medical Center
・埼玉医科大学（埼玉県） Saitama Medical University Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032442
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