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

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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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name