UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006723 |
|---|---|
| Receipt number | R000007940 |
| Scientific Title | Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa. |
| Date of disclosure of the study information | 2011/11/14 |
| Last modified on | 2019/11/20 10:28:07 |
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Basic information
Public title
Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa.
Acronym
Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa.
Scientific Title
Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa.
Scientific Title:Acronym
Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa.
Region
| Japan |
Condition
Condition
Epidermolysis bullosa (junctional, dystrophic)
Classification by specialty
| Hematology and clinical oncology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of family donor-derived bone marrow mesenchymal stem cell transplantation to the patients with junctional and dystrophic epidermolysis bullosa.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation
(Adverse events)
Key secondary outcomes
Efficacy evaluation
(macroscopic and histological examination of the skin lesions)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Subcutaneous transplantation of bone marrow mesenchymal stem cells
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with epidermolysis bullosa (junctional or dystrophic type).
2) Patients aged 20-60 years old.
3) Patients with intractable skin ulcer which present for more than 6 weeks.
4) Patients who have opposite-sex parent or sibling with donor agreement.
5) Patients who agreed with written concent
Key exclusion criteria
1) Patients with severe psychotic disorders
2) Patients with alcoholic addiction
3) Patients with disturbance of consciousness
4) Patients with history of malignancy within the last 5 years
5) Patients with pregnancy
6) Patients with diabetes
Other patients who are evaluated not to be suitable for this research
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuto Tamai |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Stem Cell Therapy Science
Zip code
Address
2-2, Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3902
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Hospital
Division name
Medical Center for Translational Research
Zip code
Address
2-15, Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
大阪大学医学部附属病院（大阪府）/Osaka University Hospital (Osaka)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 14 | 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
| 2011 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 02 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 14 | Day |
Last modified on
| 2019 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
