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Investigating the effect of intravenous injection of deciduous tooth pulp mesenchymal stem cells in patients with uncompensated liver cirrhosis in order to reduce the complications of the disease

Protocol summary

Study aim
Determining the effect of intravenous injection of mesenchymal stem cells of deciduous tooth pulp in reducing complications in patients with liver cirrhosis.
Design
Clinical trial with control group, with parallel groups, without blinding, specific non-randomized to control and intervention groups, phase 1 on 10 patients
Settings and conduct
This study will be conducted on patients with liver cirrhosis in Kerman University of Medical Sciences and Afzalipur Hospital in Kerman. After selecting the patients, they will be divided into 2 groups of 5 people and the intervention group will be injected with mesenchymal stem cells. Patients will be followed up at specific time intervals.
Participants/Inclusion and exclusion criteria
Entry conditions: patients with decompensated liver cirrhosis Exclusion conditions: people with underlying malignant disease, extrahepatic biliary disease, active thrombosis in the hepatic or portal vein, respiratory and renal failure, active infection, diabetes mellitus, cardiovascular diseases and uncontrolled blood pressure, and liver transplant candidates. and pregnant women
Intervention groups
In the intervention group, in addition to the usual treatments, 1 million cells per kilogram of body weight are injected intravenously 3 times, 1 month apart. In the control group, the patients will undergo their routine treatments and will be followed up like the intervention group.Patients will be followed up 3 and 6 months after injection.
Main outcome variables
To check the results, liver function tests including serum albumin, prothrombin activity, bilirubin and creatinine, as well as clinical evaluations including ascites are performed.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140911019125N11
Registration date: 2024-08-05, 1403/05/15
Registration timing: prospective

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32 24618
Email address
afarsinejad@kmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intravenous injection of deciduous tooth pulp mesenchymal stem cells in patients with uncompensated liver cirrhosis in order to reduce the complications of the disease
Public title
Investigating the effect of mesenchymal stem cell injection on reducing complications in patients with liver cirrhosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having clinical and laboratory manifestations related to uncompensated liver cirrhosis Age between 18 and 65 years Absence of pregnancy in women There is no specific treatment for cirrhosis Consent to participate in the study
Exclusion criteria:
Having an underlying malignancy Evidence of extrahepatic biliary diseases Active thrombosis in the hepatic or portal vein Respiratory or kidney failure Active infection Liver transplantion candidate patients Patients with diabetes mellitus Patients with severe cardiovascular disease and high blood pressure not controlled by medication The presence of severe underlying diseases pregnant women
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Kerman University Of Medical Science
Street address
Haft Bagh Blvd, Kerman University Of Medical Science
City
Kerman
Province
Kerman
Postal code
7616911333
Approval date
2024-07-22, 1403/05/01
Ethics committee reference number
IR.KMU.REC.1403.183

Health conditions studied

1

Description of health condition studied
Reducing complications of liver failure in patients with decompensated liver cirrhosis
ICD-10 code
P78.81
ICD-10 code description
Congenital cirrhosis (of liver)

Primary outcomes

1

Description
Check liver function
Timepoint
At intervals of 3 and 6 months after injection
Method of measurement
Examining the laboratory parameters of the patient related to the liver with a laboratory device

2

Description
Evaluation of the Child-pugh criterion
Timepoint
3 and 6 months after injection
Method of measurement
Completing certain questionnaires according to laboratory and clinical results of patients

3

Description
Evaluation of the MELD criterion
Timepoint
3 and 6 months after injection
Method of measurement
Completing certain questionnaires according to laboratory and clinical results of patients

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, after selecting the patients, a sample of mesenchymal stem cells is injected intravenously at the rate of 1 million per kilogram of body weight, 3 times, 1 month apart.
Category
Treatment - Other

2

Description
Control group: The control group is people who will not receive any injection of mesenchymal stem cells. And they will only receive the usual treatments and interventions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipur Kerman Hospital, Gastroenterology Department
Full name of responsible person
Omid Eslami
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
o_eslami@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Haft bagh Blvd. kerman university of medical science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3226 3855
Email
Iranpourabedin89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft bagh Blvd, kerman university of medical science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft Bagh Blvd,Kerman University Of Medical Science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft-Bagh Blvd, Kerman University Of Medical Science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In our study non of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
The data will be available for people working in academic institutions and clinicians.
Under which criteria data/document could be used
Applicants are only allowed to use received data in clinical and they are not allowed to published them.
From where data/document is obtainable
1- Phone: 034-31325374 2- e-mail: afarsinejad@kmu.ac.ir 3- Fax: 034-31325375 4- address: Haft bagh Blvd, Kerman university of medical science Dr. Alireza Farsinejad
What processes are involved for a request to access data/document
Applicant can receive information after contact and send e-mail up to 10 days.
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