UMIN-CTR Clinical Trial

Basic information
Public title	A systematic review of mitochondrial transplantation therapy on ischemia reperfusion injury
Acronym	A systematic review of mitochondrial transplantation therapy on ischemia reperfusion injury
Scientific Title	A systematic review of mitochondrial transplantation therapy on ischemia reperfusion injury
Scientific Title:Acronym	A systematic review of mitochondrial transplantation therapy on ischemia reperfusion injury
Region	North America

Condition
Condition	Critical illness
Classification by specialty	Medicine in general Surgery in general Neurosurgery Cardiovascular surgery Laboratory medicine Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this systematic review is to undertake a systematic review of relevant animal and human studies to summarize current evidence of mitochondrial transplantation as a novel therapeutic strategy on ischemia reperfusion injury under critical illness. P: Ischemia reperfusion injury I: Mitochondrial transplantation O: Biological or physiological measures of the ischemia reperfusion injury. S: RCT, other intervention studies, cohort studies, animal studies
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biological or physiological measures of the ischemia reperfusion injury.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	P: Critical illness related to ischemia reperfusion injury including myocardial infarction, organ transplantation, cardiac arrest, and acute brain injury. I: Intraarterial or intravenous injection, or direct injection into the region at risk with isolated mitochondria. O: Biological or physiological measures of the ischemia reperfusion injury. S: RCT, other intervention studies, cohort studies, animal studies 1. Studies published in peer-reviewed journals. 2. Studies published as research papers which enabled to obtain a full text.
Key exclusion criteria	1. Studies that used a mesenchymal stem cell-mediated transfer of mitochondria as a transfer method 2. Studies under cell culture conditions
Target sample size

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Hayashida
Organization	Feinstein Institutes for Medical Research
Division name	Emergency medicine
Zip code	11030
Address	350 Community Drive, Manhasset, NY
TEL	1-516-562-1305
Email	keilinda0714@gmail.com

Public contact
Name of contact person	1st name Kei Middle name Last name Hayashida
Organization	Feinstein Institutes for Medical Research
Division name	Emergency medicine
Zip code	11030
Address	350 Community Drive, Manhasset, NY
TEL	1-516-562-1305
Homepage URL
Email	keilinda0714@gmail.com

Sponsor
Institute	Feinstein Institutes for Medical Research
Institute
Department

Funding Source
Organization	Feinstein Institutes for Medical Research
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Feinstein Institutes for Medical Research
Address	Emergency medicine
Tel	1-516-562-1305
Email	keilinda0714@gmail.com

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	2021 Year 02 Month 17 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	2021 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 17 Day
Last follow-up date	2021 Year 02 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Systematic review

Management information
Registered date	2021 Year 02 Month 17 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049492