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 | 2025/02/22 09:33:32 |
* 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
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
Lactic acid and various TCA cycle-related substances accumulate in the blood of patients with mitochondrial disease, and this is also a diagnostic criterion. Therefore, we will measure the blood concentrations of various metabolites from blood and urine samples obtained during the course of treatment of patients, comprehensively analyze the metabolome of intracellular low molecular weight compounds in fibroblasts, and investigate the reactivity of various compounds to stress responses to develop new therapeutic drugs.
Base
Study type
Observational
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
| Not applicable |
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 | Takaaki |
| Middle name | |
| Last name | ABE |
Organization
Tohoku University Graduate School of Biomedical Engineering,
Division name
Division of Medical Science
Zip code
9898574
Address
1-1 Seiryo-cho, Aaoba-ku, Sendai 980-8574 Japan
TEL
022-717-7163
takaabe@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | ABE |
Organization
Tohoku University Hospital
Division name
Division of Clinical Biology and Hormonal Regualtion
Zip code
989-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai 980-8574 Japan
TEL
022-717-7163
Homepage URL
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
Tohoku University
Address
1-1 Seiryo-cho, Aoba, Sendai, Japan
Tel
022-717-7163
takaabe@med.tohoku.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
| 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
| 2025 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017297
