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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000006723
Date of registration: 14/11/2011
Prospective Registration: Yes
Primary sponsor: Osaka University Graduate School of Medicine
Public title: Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa.
Scientific title:
Date of first enrolment: 2011/12/01
Target sample size: 6
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007940
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name:    
Address:  2-15, Yamadaoka, Suita-shi, Osaka 565-0871, Japan Japan
Telephone:
Email:
Affiliation:  Osaka University Hospital Medical Center for Translational Research
Name: Katsuto Tamai   
Address:  2-2, Yamadaoka, Suita-shi, Osaka 565-0871, Japan Japan
Telephone: 06-6879-3902
Email:
Affiliation:  Osaka University Graduate School of Medicine Department of Stem Cell Therapy Science
Key inclusion & exclusion criteria
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

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


Age minimum: 20years-old
Age maximum: 60years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Epidermolysis bullosa (junctional, dystrophic)
Intervention(s)
Subcutaneous transplantation of bone marrow mesenchymal stem cells
Primary Outcome(s)
Safety evaluation
(Adverse events)
Secondary Outcome(s)
Efficacy evaluation
(macroscopic and histological examination of the skin lesions)
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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