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Study of the effect of intravenous injection of Deciduous dental pulp mesenchymal stem cell in hematopoietic stem cell engraftment after autologus hematopoietic stem cell transplantation (HSCT) in patients with Hodgkin and non-Hodgkin Lymphoma

Protocol summary

Study aim
Determining the effect of intravenous injection of deciduous tooth pulp mesenchymal stem cells on the regeneration process of blood cells after autologous hematopoietic stem cell transplantation in patients with Hodgkin Lymphoma and Non-Hodgkin Lymphoma.
Design
Clinical trial with control group, with parallel groups, without blinding, specific non-randomized to control and intervention groups, phase 1 on 30 patients
Settings and conduct
This study is done in the field of bone marrow transplantation. The place where it is performed is Afzalipur Hospital and the Innovation Center of Stem Cells and Regenerative Medicine. After selecting the patients, they are divided into 3 control groups, intervention 1 and intervention 2, and mesenchymal stem cells are injected according to the mentioned method.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Patients with Hodgkin's and non-Hodgkin's lymphomas who are candidates for autologous bone marrow transplantation Exclusion Criteria: Patients who serologically positive for HIV and HTLV-1, HBV, HCV. with coronary artery insufficiency, recent myocardial infarction, patients with recent manifestations of heart failure
Intervention groups
In intervention group 1, 1 million cells per kilogram of the person's body weight are injected 4 hours before the injection of hematopoietic stem cells. In intervention group 2, 1 million cells per kilogram of body weight will be injected in a divided manner on days 0, +2, +4, +6 after transplantation.Patients who are in the control group will receive routine treatments related to hematopoietic stem cell transplantation and will be followed up like the intervention groups.
Main outcome variables
Counting and checking blood parameters after transplantation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140911019125N10
Registration date: 2024-05-29, 1403/03/09
Registration timing: prospective

Last update: 2024-05-29, 1403/03/09
Update count: 0
Registration date
2024-05-29, 1403/03/09
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
Study of the effect of intravenous injection of Deciduous dental pulp mesenchymal stem cell in hematopoietic stem cell engraftment after autologus hematopoietic stem cell transplantation (HSCT) in patients with Hodgkin and non-Hodgkin Lymphoma
Public title
Investigating the effect of mesenchymal stem cells of deciduous tooth pulp on regeneration of the hematopoietic system after hematopoietic stem cell transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18 and 70 years Patients with Hodgkin's and non-Hodgkin's lymphomas who are candidates for autologous bone marrow transplantation Not having uncontrollable infections, liver, kidney, lung and heart problems based on transplant criteria
Exclusion criteria:
Patients with uncontrollable infection Patients who are serologically positive for HIV and HTLV-1, HBV, HCV. Patients with coronary artery insufficiency, recent myocardial infarction, patients with recent manifestations of heart failure Patients with renal failure and urinary tract obstruction Patients with a history of sensitivity to conditioning chemotherapy drugs Patient dissatisfaction
Age
From 18 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 30
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
2024-05-28, 1403/03/08
Ethics committee reference number
IR.KMU.REC.1403.092

Health conditions studied

1

Description of health condition studied
Outcomes after autologous hematopoietic stem cell transplantation
ICD-10 code
D77
ICD-10 code description
Other disorders of blood and blood-forming organs in diseases classified elsewhere

Primary outcomes

1

Description
Investigating the rate of regeneration of white blood cells
Timepoint
daily until discharge from the hospital
Method of measurement
Counting with a blood cell counter

2

Description
Investigating the regeneration rate of platelets
Timepoint
daily until discharge from the hospital
Method of measurement
Counting with a blood cell counter

3

Description
Checking the increase in hemoglobin
Timepoint
daily until discharge from the hospital
Method of measurement
with blood cell counter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first intervention group, after the selection of the patient, a sample of mesenchymal stem cells from the deciduous tooth pulp will be injected intravenously at the rate of 1 million per kilogram of body weight 4 hours before the injection of hematopoietic stem cells.
Category
Treatment - Other

2

Description
Intervention group: In the second intervention group, after selecting the patient, according to the patient's weight, a divided dose of mesenchymal stem cells will be injected intravenously on day 0, +2, +4, +6 after hematopoietic stem cell transplantation. .
Category
Treatment - Other

3

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 related to hematopoietic stem cell transplantation.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipur Kerman Hospital, bone marrow transplant department
Full name of responsible person
Vahid Moazed
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
maazed@kmu.ac.ir

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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