Determining the effect of stem cell injection on clinical symptoms and echocardiographic findings of children with primary pulmonary artery hypertension
Determining the effect of stem cell injection on clinical symptoms and echocardiographic findings of children with primary pulmonary artery hypertension
Design
A number of 20 children and adolescents with primary pulmonary hypertension will be included in the study. They will be subjected and controlled by simple randomization in two groups of 10 people.
The secondary causes of pulmonary hypertension and concomitant congenital heart disease are conditions for exclusion from the study.
Settings and conduct
In the control group, endothelial receptor inhibitor (Liratan) is prescribed at a dose of 0.1 mg per body weight daily. In the intervention group, in addition to the aforementioned standard treatment, stem cells extracted from the dental pulp will be injected according to the protocol. Before and after the injection. At specific time intervals of 24, 72 hours, one and a half months after the injection, clinical parameters (walking capacity in 6 minutes and arterial oxygen saturation), and ecocardiographic finding related to pulmonary hypertension and right ventricular function will be measured and recorded.
Participants/Inclusion and exclusion criteria
Patients aged 3-18 years with primary pulmonary hypertension
Intervention groups
In the intervention group, after temporary hospitalization, processed stem cells are injected to the patients, and for the control group, oral medicine is prescribed on an outpatient basis.
Main outcome variables
pulmonary arterial pressure
General information
Reason for update
Acronym
PAH
IRCT registration information
IRCT registration number:IRCT20210317050737N2
Registration date:2023-02-06, 1401/11/17
Registration timing:registered_while_recruiting
Last update:2023-02-06, 1401/11/17
Update count:0
Registration date
2023-02-06, 1401/11/17
Registrant information
Name
Maryam Ahmadipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3247 0346
Email address
m.ahmadipour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of stem cell injection on clinical symptoms and echocardiographic findings of children with primary pulmonary artery hypertension
Public title
The role of stem cells in the treatment of primary pulmonary hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 3-8 years diagnosed with primary pulmonary hypertension
Exclusion criteria:
Accompanying congenital heart disease
Secondary causes of pulmonary hypertension
Age
From 3 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
With the simple random method, random selection method is used to determine the position of the first sample. Names of patients are written on similar papers and placed in a bag.The first paper is randomly take out from the bag. This number represents the first person who is placed in the stem cell injection group, the patient with the next number enters the drug treatment group and this is repeated in order until the sample volume is complete.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The use of stem cells in the treatment of pulmonary hypertension is currently limited
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Afzalipour Hospital,Emam Blvd,Kerman Town
City
kerman
Province
Kerman
Postal code
7616913355
Approval date
2022-10-30, 1401/08/08
Ethics committee reference number
IR.KMU.AH.REC.1400.181
Health conditions studied
1
Description of health condition studied
Primary pulmonary hypertension
ICD-10 code
I27.0
ICD-10 code description
Primary pulmonary hypertension
Primary outcomes
1
Description
pulmonary arterial pressure
Timepoint
Before injection and after injection at intervals of 24 and 48 hours, one and 6 months later
Method of measurement
Transthoracic echocardiography
2
Description
6 minute walk test
Timepoint
Before injection and after injection at intervals of 24 and 48 hours, one and 6 months later
Method of measurement
Observing and measuring the distance traveled
3
Description
Arterial oxygen saturation percentage
Timepoint
Before injection and after injection at intervals of 24 and 48 hours, one and 6 months later
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Stem cell injection of one and a half milliliter per kilogram of the patient's weight from processed stem cells with a concentration of one million stem cells in 200 microliters intravenously and through a peripheral vein.
Category
Treatment - Drugs
2
Description
Control group: Prescription of tadalafil at the rate of1 milligram per kilogram weight per day for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Maryam Ahmadipour
Street address
Afzalipour Hospital,Emam Blvd,
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 2235 0118
Email
maryam.ahmadipour5@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Ahmadipour
Street address
Afzalipour Hospital،Emam Blvd,
City
kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 2235 0118
Email
maryam.ahmadipour5@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
Maryam Ahmadipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Afzalipour Hospital,Emam Blvd
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 2235 0118
Email
maryam.ahmadipour5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Ahmadipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Afzalipour Hospital ,Emam Blvd
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 2235 0118
Email
maryam.ahmadipour5@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Ahmadipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Afzalipour Hospital,Emam Blvd
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 2235 0118
Email
maryam.ahmadipour5@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available