UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026645 |
|---|---|
| Receipt number | R000030601 |
| Scientific Title | A Clinical Study to Evaluate the Efficacy and Safety of JR-031 in Patients with Epidermolysis Bullosa |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2018/08/01 15:52:36 |
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Basic information
Public title
A Clinical Study to Evaluate the Efficacy and Safety of JR-031 in Patients with Epidermolysis Bullosa
Acronym
A Clinical Study to Evaluate the Efficacy and Safety of JR-031 in Patients with Epidermolysis Bullosa
Scientific Title
A Clinical Study to Evaluate the Efficacy and Safety of JR-031 in Patients with Epidermolysis Bullosa
Scientific Title:Acronym
A Clinical Study to Evaluate the Efficacy and Safety of JR-031 in Patients with Epidermolysis Bullosa
Region
| Japan |
Condition
Condition
Epidermolysis Bullosa
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of JR-031 in patients with Epidermolysis Bullosa
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of patients number who show 50% or more improvement in the size of
cutaneous ulcer after 48 week treatment
Key secondary outcomes
1) Changes from baseline in the size of
cutaneous ulcer after 1,2,4,8,16,24,32,40,48 week treatment
2) Rate of patients number who show 50% or more improvement in the size of
cutaneous ulcer after 1,2,4,8,16,24,32,40 week treatment
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
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
JR-031 is subcutaneously administered at the dose of 0.5 million cells /250 micro L /site every two centimeters around cutaneous ulcers. The maximum number of injection sites is 40 and the maximum dose is 20 million cells /man.
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 diagnosed as Epidermolysis Bullosa
2) Patients who have skin ulcers which last more than 12 months
3) Patients who is 6 years old or elder and younger than 70 years old
Key exclusion criteria
1) Patients who received a therapy with mesenchymal stem cell derived from human bone marrow or TEMUCELL HS injection.
2) Patients who are suffering from serious mental diseases.
3) Patients who are suffering from cancer or who have histories of suffering from cancer within 5 years prior to enrollment.
4) Patients who are pregnant or probably pregnant.
5) Patients who do not agree to take effective contraceptive measures during the study period.
6) Patients who have entered other clinical trials within 6 months prior to enrollment.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuto Tamai |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Stem Cell Therapy Science
Zip code
Address
2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6210-8396
tamai@gts.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuto Tamai |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Stem Cell Therapy Science
Zip code
Address
2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6210-8396
Homepage URL
tamai@gts.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 24 | 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 | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2018 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030601
