UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014874
Receipt number R000017297
Scientific Title Development of Drugs for Mitochomdrial Diseases Using Patient's Skin Fibroblasts
Date of disclosure of the study information 2014/09/01
Last modified on 2016/08/17 09:11:20

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Basic information

Public title

Development of Drugs for Mitochomdrial Diseases Using Patient's Skin Fibroblasts

Acronym

Developing Drgus for Mitochondrial Diseases

Scientific Title

Development of Drugs for Mitochomdrial Diseases Using Patient's Skin Fibroblasts

Scientific Title:Acronym

Developing Drgus for Mitochondrial Diseases

Region

Japan


Condition

Condition

Mitochondrial diseases

Classification by specialty

Medicine in general Cardiology Hematology and clinical oncology
Nephrology Neurology Clinical immunology
Pediatrics Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To isolate and culture Patient's skin fibroblast and examine the protective effect of various newly developped drugs

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

To isolate and culture Patient's skin fibroblast and examine the protective effect of various newly developped drugs

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

0 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients diagnosed with MItochondrial disease

Key exclusion criteria

Non patient

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name ABE Takaaki

Organization

Tohoku University Graduate School of Biomedical Engineering,

Division name

Division of Medical Science

Zip code


Address

1-1 Seiryo-cho, Aaoba-ku, Sendai 980-8574 Japan

TEL

022-717-7163

Email

takaabe@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name ABE Takaaki

Organization

Tohoku University Hospital

Division name

Division of Clinical Biology and Hormonal Regualtion

Zip code


Address

1-1 Seiryo-cho, Aoba-ku, Sendai 980-8574 Japan

TEL

022-717-7163

Homepage URL


Email

takaabe@med.tohoku.ac.jp


Sponsor or person

Institute

ABE Takaaki
Tohoku Univerisity Hospital

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


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 09 Month 01 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

Enrolling by invitation

Date of protocol fixation

2014 Year 02 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is isolating skin fibroblast form Mitochondrial disease patient and develop new drugs.
It will be also perform metabolic analysis to develop diagnostic tool for evaluating drug efficacy.


Management information

Registered date

2014 Year 08 Month 16 Day

Last modified on

2016 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017297


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name