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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000028366 |
Receipt No. | 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 | 2020/07/27 |
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 |
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Condition | ||
Condition | dystrophic epidermolysis bullosa | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 5 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Ishin Pharmaceutical Co. Ltd. |
Institute | |
Department |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032442 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
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