UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014883 |
|---|---|
| Receipt number | R000017065 |
| Scientific Title | Feasibility study of the treatment of the refractory skin ulcer by the punch graft from the Natural gene therapy area in epidermolysis bullosa |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2017/02/20 13:10:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility study of the treatment of the refractory skin ulcer by the punch graft from the Natural gene therapy area in epidermolysis bullosa
Acronym
Punch graft from natural gene therapy area in epidermolysis bullosa
Scientific Title
Feasibility study of the treatment of the refractory skin ulcer by the punch graft from the Natural gene therapy area in epidermolysis bullosa
Scientific Title:Acronym
Punch graft from natural gene therapy area in epidermolysis bullosa
Region
| Japan |
Condition
Condition
epidermolysis bllosa
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In order to evaluate the efficacy and safety of skin transplantation using punch grafts from "natural gene therapy" area in the bullous epidermolysis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We evaluate the rate of reepithelialization for the 4th week after the last grafting (%)
Key secondary outcomes
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 | Other |
Interventions/Control_1
skin transplantation using punch grafting from natural gene therapy area to refractory ulcer
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with epidermolysis bullosa (junctional or dystrophic type)and fulfills as follows:
1.Patient aged 6 years old and up.
2.Patient whose responsible gene for epidermolysis bullosa has been identified.
3.Patient with the skin area in which a natural gene therapy occur.
4.Patients with intractable skin ulcers of bigger than 5 cm2 in size which last for more than 2 weeks.
5.Patient who agreed with genetic ecamination of the skin.
6.Patients who agreed with written informed consent after satisfactory explanation.
Key exclusion criteria
1.Patient who has participated in other clinical trials in recent 3 months.
2.Patient who is participating or will participate in other clinical trials.
3. Patients with malignancy except skin malignancy.
4.Patients with pregnancy
5.The patient who may suffer an unjust disadvantage by not participating in this research.
6.Other patients who are evaluated not to be suitable for this research
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Fujita |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
North 15 West 7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-7387
yfujita@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Fujita |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
North 15 West 7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-7387
Homepage URL
yfujita@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology
Hokkaido University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 20 | 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
| 2014 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 18 | Day |
Last modified on
| 2017 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017065
