UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037612 |
|---|---|
| Receipt number | R000042877 |
| Scientific Title | Clinical study of autologous noncultured epidermal cell transplantation for leukoderma treatment |
| Date of disclosure of the study information | 2019/08/08 |
| Last modified on | 2019/08/14 11:29:48 |
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Basic information
Public title
Clinical study of autologous noncultured epidermal cell transplantation for leukoderma treatment
Acronym
Clinical study of autologous noncultured epidermal cell transplantation for leukoderma treatment
Scientific Title
Clinical study of autologous noncultured epidermal cell transplantation for leukoderma treatment
Scientific Title:Acronym
Clinical study of autologous noncultured epidermal cell transplantation for leukoderma treatment
Region
| Japan |
Condition
Condition
Stable vitiligo
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of autologous noncultured epidermal cell transplantation in vitiligo
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluation of repigmentation rate of cell transplantation area (test site), suction blister transplantation area (comparison site), non-treated area (control site) by calculating the area of images taken by digital camera.Photographs are taken before, 3 months after and 6 months after the operation. Observation of the wound areas of donor site, test site, comparison site and control site as a safety evaluation.
Key secondary outcomes
Evaluation of color matching (melanin and hemoglobin) on the test site, comparison site, control site and peripheral healthy site by the Mexameter. Incidence of adverse effects like infection, scarring and hemorrhoids resulting from the regenerative medicine as a safety evaluation. Color matching and safety evaluation are performed before, 3 months after and 6 months after the operation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
noncultured epidermal cell transplantation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women aged over 20 years old with a diagonosis of stable vitiligo who visited the department of dermatology Osaka University Hospital and who signed a written informed consent by themselves after receiving the explanation of clinical study.
Key exclusion criteria
Apparently unstable patients defined as new areas of depigmentation or enlarging areas of depigmentation within the last 12 months.
Patients with treatment of steroid, active vitamin D3, calcineurin inhibitor and light radiation therapy within the 4 weeks befor registration.
History of keloidal scars and presence of Koebner's phenomenon
Patients with allergies to antibiotics and local anaesthetics
Patients with tape rash
Pregnant women, lactating women and patients who deaire pregnancy during clinical studies.
Positive serology of Hepatitis B and C, HIV, HTLV-1
Patients who are participating in other clinical studies including interventions or non-interventions such as observation studies.
Investigators judge the patiens should not paticipate in the study for any reason
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanemura |
Organization
Osaka University Graduate School of Medicine
Division name
Development of Dermatology
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka Japan
TEL
06-6879-3031
tanemura@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanemura |
Organization
Osaka University Graduate School of Medicine
Division name
Development of Dermatology
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka Japan
TEL
06-6879-3031
Homepage URL
http://derma.med.osaka-u.ac.jp/
tanemura@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka City University, Department of Pigmentation Research and Therapeutics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka Japan
Tel
06-6210-8296
handai-nintei@hp-crc.med.osaka-u.ac.jp
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
| 2019 | Year | 08 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042877
