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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 2018/01/23

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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
Middle name
Last name Teikichi Aoyagi
Organization Ishin Pharmaceutical Co. Ltd.,
Division name Clinical development department
Zip code
Address 2-3-11 Nihonbashi-honcyo, Chuo-ku, Tokyo, Japan.
TEL 03-6262-5243
Email aoyagi@ishinpharma.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sadao Kikuta
Organization Ishin Pharmaceutical Co. Ltd.,
Division name Clinical development department
Zip code
Address 2-3-11 Nihonbashi-honcyo, Chuo-ku, Tokyo, Japan.
TEL 03-6262-5243
Homepage URL
Email 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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 25 Day
Last modified on
2018 Year 01 Month 23 Day


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
Registered date File name


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