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Evaluation of safety of mitochondrial transplantation extracted from platelets in brain ischemic stroke: Clinical trial Phase I

Protocol summary

Study aim
Evaluation of mitochondrial transplantation on mortality in patients with cerebral ischemia after transplantation Evaluation of mitochondrial transplantation on the incidence of cerebral hemorrhage after transplantation Evaluation of mitochondrial transplantation on the incidence of post-transplant brain cancer Evaluation of mitochondrial transplantation on systemic complications such as heart disease, seizures, worsening of the patient and increase in NIHSS index after mitochondrial transplantation
Design
Randomized with control, parallel and blinded study on 10 patients. Clinical trial I
Settings and conduct
This clinical trial will be performed on 10 brain stroke patients in Poursina Hospital in Rasht. The study is blinded.
Participants/Inclusion and exclusion criteria
-Patients who have recently had a stroke and have not had a stroke for more than 24 hours are selected. -Patients from both sexes and over 40 years are selected. -Patients who able to fill the informed consent of the research project. Exclusion criteria - Patients with mitochondrial disorders. -Patients who are in a coma and have score 1 or 2 according to the NIHSS criteria to assess the level of consciousness. -Aphasis -Inability or unwillingness of the individual or legal guardian / representative to provide informed written consent Patients who do not participate/collaborate to follow up
Intervention groups
In this study, patients are divided into control groups and mitochondrial groups. The control group will receive only respiratory buffer solution that does not contain mitochondria. Treatment group will receive the mitochondria extracted from mitochondria.
Main outcome variables
Mortality rate Bleeding rate adverse side effects The incidence of cancer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210212050334N1
Registration date: 2021-02-16, 1399/11/28
Registration timing: prospective

Last update: 2021-02-16, 1399/11/28
Update count: 0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Amaneh Mohammadi Roushandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 1520
Email address
mohammadi_roushandeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-12-20, 1400/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety of mitochondrial transplantation extracted from platelets in brain ischemic stroke: Clinical trial Phase I
Public title
Evaluation of safety of mitochondrial transplantation extracted from platelets in brain ischemic stroke: Clinical trial Phase I
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
-Patients who have recently had a stroke and have not had a stroke for more than 24 hours are selected . .-Patients from both sexes and over 40 years are selected. -Patients who able to fill the informed consent of the research project. The text of the consent form with full explanation of the nature and purpose of this study must be signed by the patient or their supervisor or legal representative. For example, if a patient fails to sign a consent form in case of confusion or loss of consciousness, it is the responsibility of a close relative Negative pregnancy test for women who are at reproductive age. -- Clinical diagnosis of stroke in patients using computed tomography (CT) or magnetic resonance imaging Brain MRI + DWI (MRI) show acute ischemia in the right middle cerebral artery. - Patients are evaluated and scored according to the National Stroke Institute (NIHSS) scale. Accordingly, patients who get a score of 8 to 20 on this scale will be selected.
Exclusion criteria:
- Patients with mitochondrial disorders. -Patients who are in a coma and have score 1 or 2 according to the NIHSS criteria to assess the level of consciousness. -Aphasia -Imaging of patients' brain using CT scan and MRI that may show signs of tumor, cerebral edema, increased intraventricular pressure, intracerebral hemorrhage, or cerebral infarction. -Patients who currently have and/ or had a history of drug or alcohol abuse are excluded from the study. -Patients with active infectious diseases, including HIV, hepatitis B and C, are excluded from the study. -Patients with dementia. -Patients participating in another clinical trial. Any specific clinical conditions or health conditions, such as decreased life expectancy, or multiple illnesses at the same time, or other conditions that prevent proper diagnosis, treatment, or follow up of the disease in the testing process, are excluded from the study. -Inability or unwillingness of the individual or legal guardian / representative to provide informed written consent Patients who do not able to collaborate for follow up
Age
From 41 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization is used for randomization. The Quadruple blocks are used and the ratio is 1: 1. Blocking is not done through software and is done manually. Sequences are marked in closed envelopes with the letters A and B in which the letter A is allocated for intervention group and letter B is allocated for control group. In this randomization, blindness is also determined and only the person who is responsible for the extraction of mitochondria will be responsible for doing the work.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients know that they are going to be involve in a project. Participants who completed the informed consent are two groups of control and intervention who are blinded to with mitochondria or buffer. The principal investigator and the treating physician and all those who interact with the patient in some way are blinded like the nurses. Those who analyze the data are also blinded. The Data Safety and Monitoring Committee and those who analyze the outcome are also blinded. The only person who is not blinded is the one who extracts the mitochondria. The draft article will be written after the completion of the project as well as obtaining all the results and data. The author of the draft article is the main researcher who has been blinded from the beginning.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Guilan University of Medical Sciences
Street address
Anatomical Sciences Department, Medicine faculty, Guilan University of Medical Sciences, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2021-02-07, 1399/11/19
Ethics committee reference number
IR.GUMS.REC.1399.587

Health conditions studied

1

Description of health condition studied
Brain ischemia
ICD-10 code
I63
ICD-10 code description
Cerebral infarction

Primary outcomes

1

Description
Mortality rate
Timepoint
24hour, one week, six months, one year
Method of measurement
The death rate is indicated by a number.

2

Description
- Systemic and adverse Side effects after 24, one week and six months and one year
Timepoint
24hour, one week, six months, one year
Method of measurement
Barometer, EKG, NIHSS

3

Description
Brain Bleeding
Timepoint
24hour, one week, six months, one year
Method of measurement
National Institutes of Health stroke scale score, MRI

4

Description
cancer incidence
Timepoint
Six months , one year
Method of measurement
MRI

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The product that is going to be transplanted is mitochondria. Patients will receive approximately 500,000 platelet-derived mitochondria intravenously three times at one-hour intervals.
Category
Treatment - Other

2

Description
Control group: In this group only the respiration buffer is injected.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina hospital
Full name of responsible person
Amaneh Mohammadi Roushandeh
Street address
Poursina hospital-Parastar street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
mohammadi_roushandeh@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Deputy of research and technology, shahid siadati street, Namjoo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Web page address
https://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Amaneh Mohammadi Roushandeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Anatomical Sciences department, Medicine faculty, Guilan University of Medical Sciences, rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
mohammadi_roushandeh@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mehryar Habibi Roudkenar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Burn and regenerative medicine research center, Velayat hospital, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
mhr376@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Amaneh Mohammadi Roushandeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Anatomical Sciences Department, Medicine Faculty, Guilan University of Medical Sciences, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
mohammadi_roushandeh@gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Age, sex, mortality rate, cancer incidence, bleeding and side effects
When the data will become available and for how long
After publishing of the results in the journal
To whom data/document is available
Universities
Under which criteria data/document could be used
Only for studying not for analysis
From where data/document is obtainable
Amaneh Mohammadi Roushandeh dinachal@yahoo.com
What processes are involved for a request to access data/document
The application must be written to the Deputy of Research and technology of Guilan University of Medical Sciences. From there, the request is sent to the principle investigator and the researcher sends the documents to the deputy. The applicant can receive the documents from the deputy.
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