Determining the safety, feasibility and effectiveness of secretome derived from mesenchymal stem cells for GVHD patients
Design
This study will have a control group in parallel with the simple randomization method. The type of study will be triple-blinded in phase 3 on 30 patients.
Settings and conduct
In this clinical trial study, 30 patients with GVHD, who were referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 groups of 15 people, and the intervention and control groups received secretome and distilled water by injection, respectively. The method of blinding will be triple-blinded and all the names and personal information of the patients will be coded at the time of data collection and will remain completely confidential.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with acute GVHD with fever requiring hospitalization
Exclusion criteria:
1- Having sepsis
Intervention groups
1- Secretome recipient group
2- Control group receiving distilled water
Main outcome variables
Skin rash, liver involvement, intestine condition
General information
Reason for update
Acronym
GVHD
IRCT registration information
IRCT registration number:IRCT20201108049311N7
Registration date:2023-09-28, 1402/07/06
Registration timing:registered_while_recruiting
Last update:2023-09-28, 1402/07/06
Update count:0
Registration date
2023-09-28, 1402/07/06
Registrant information
Name
Seyyedeh Mina Hejazian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
smhjz.biotech@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-02, 1402/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mesenchymal stem cells derived from the placenta and their secretome for the treatment of GVHD: A triple-blinded randomized clinical trial
Public title
Mesenchymal stem cells derived from the placenta and its secretions in the treatment of graft versus host disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute GVHD with fever and requiring hospitalization
Exclusion criteria:
Patients with sepsis
Age
From 16 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty men and women with GVHD will be randomly assigned into two groups receiving intravenous secretome (15 people) or distilled water (15 people) using the random block method using blocks 4 and 6 through RAS (Random Allocation Software) and allocation ratio 1:1. In order to conceal the allocation, the secretome and distilled water will be placed in opaque vials numbered from 1 to 30. Participants will receive vials numbered 1 to 30 based on the order of entering the study. Preparing the vials and numbering them will be done based on the generated random sequence by a person not involved in the research.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be a triple-blinded study. In this way, the doctor will introduce the patients to receive secretome/distilled water and will not be aware of the grouping. Participating volunteers will not know about receiving secretome, distilled water, or other drugs. Secretome and distilled water will be placed in similar and coded vials. In addition, the placebo (distilled water) will be identical in appearance (shape and color), taste, and smell with secretome. In addition, due to the coding of patients and the lack of clarity in the grouping of patients, the data analyzer will be also blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TBZMED.REC.1402.132
Health conditions studied
1
Description of health condition studied
Graft versus host disease
ICD-10 code
D89.81
ICD-10 code description
Graft-versus-host disease
Primary outcomes
1
Description
Skin rash
Timepoint
At the beginning of the study and 6 weeks after the intervention
Method of measurement
Examination of appearance (shape, color and texture of skin rash), determination of BSA percentage and staging based on it
2
Description
Liver involvement
Timepoint
At the beginning of the study and 6 weeks after the intervention
Method of measurement
Measurement of Bilirubin level
3
Description
Intestine condition
Timepoint
At the beginning of the study and 6 weeks after the intervention
Method of measurement
Diarrhea volume measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recipient of 6 doses secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) (It will be produced through the cell culture from the placenta in the laboratory) 4 cc dissolved in albumin 20% every week for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: Recipient of 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ghazi Hospital of Tabriz
Full name of responsible person
Dr. Hussein Ghasemi Moghaddam
Street address
Daneshgah St., Shahid Ghazi Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 3811
Email
dr.ghasemi621@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Barzegari
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3336 7929
Email
barzegari.abolfazl@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hussein Ghasemi Moghaddam
Position
Subspecialty physician
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Hematology and Oncology Research Center, Shahid Ghazi Hospital, Daneshghah Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3334 3811
Email
dr.ghasemi621@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hussein Ghasemi Moghaddam
Position
Subspecialty physician
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Hematology and Oncology Research Center, Shahid Ghazi Hospital, Daneshghah Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3334 3811
Email
dr.ghasemi621@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