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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:	17 October 2023
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:	Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa. - Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa.
Date of first enrolment:	2013/07/26
Target sample size:	6
Recruitment status:	Complete: follow-up complete
URL:	https://center6.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:	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

Name:
Address:	2-15, Yamadaoka, Suita-shi, Osaka 565-0871, Japan Japan
Telephone:
Email:
Affiliation:	Osaka University Hospital Medical Center for Translational Research

Key inclusion & exclusion criteria

Inclusion criteria:
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: YES
Approval date: 03/04/2013
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	01/05/2015
URL:

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