1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Placenta mesenchymal stem cell effects on lung in veterans exposed to mustard gas
Protocol summary
Summary
Objectives: Placenta mesenchymal stem cell effects on lung in veterans exposed to mustard gas. Design: The study is phase II clinical trial which will done as before- after and not blinded. Setting and conduct: Subjects are sulphur mustard victims that will take four times cell injection along 45 days and will be assessed 3 and 6 months after the first injection. Inclusion criteria: Patients with a proven track record have mustard gas; Signed informed consent. Exclusion criteria: Underlying disease.
Intervention: The patient will placed in full flow plan in a simple language, informed consent and demographic data will be collected.The patients will be hospitalised in Sasan hospital and will be assessed by lung specialist. St.
George questionnaire form will be completed for them.
High-resolution computed tomography (HRCT) will be taken. This process will be repeated 6 months after the first injection. Before each injection, blood sampling and spirometry will be done. This stage will be repeated 3 and 6 months after the first injection. Cell injection dosage will be 100 million per patient in each injection.
During and after each injection patients will be under the supervision of experienced doctors and nurses approved by Martyr Foundation and all vital signs or possible side effects, such as fever, chills and etc will be monitored.
Main outcome measures: Primary outcomes: Quality of life Secondary outcomes: Spirometry factors;
Inflammatory markers and lung repair; HRCT findings
General information
Acronym -
IRCT registration information
IRCT registration number: IRCT2015072223298N1 Registration date: 2015-12-17, 1394/09/26 Registration timing: prospective
Last update:
Update count: 0 Registration date
2015-12-17, 1394/09/26 Registrant information
Name
Mohamad Vasei
Name of organization / entity
Tehran University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 21 8490 2187 Email address
mvasei@tums.ac.ir Recruitment status
Recruitment complete Funding source
1- Tehran University of Medical Sciences 2- Veterans Medical Science and Engineering Research Centre 3- Iranian Stem Cell Council
Expected recruitment start date 2015-12-22, 1394/10/01
Expected recruitment end date 2016-03-18, 1394/12/28 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Placenta mesenchymal stem cell effects on lung in veterans exposed to mustard gas
Public title
Placenta mesenchymal stem cell effects on mustard gas victims lung
2 Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with a proven track record have mustard gas; Signed informed consent Exclusion criteria: Underlying disease
Age
No age limit Gender
Both Phase
2
Groups that have been masked No information
Sample size
Target sample size: 10
Randomization (investigator's opinion) N/A
Randomization description Blinding (investigator's opinion)
Not blinded Blinding description Placebo
Not used Assignment
Single
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences Office of Vice- Chancellor for Global Strategies and International Affairs, Number 21, Dameshgh Street, Vali-e Asr Avenue, Tehran, Iran
City Tehran Postal code Approval date
2015-11-28, 1394/09/07
Ethics committee reference number IR.TUMS.REC.1394.1293
2
Ethics committee
Name of ethics committee
Ethics committee of Digestive Disease Research Institute
Street address
Digestive Disease Research Institute, Shariati Hospital, Kargar Shomali Avenue, Tehran, Iran
City Tehran Postal code Approval date
2015-10-17, 1394/07/25
Ethics committee reference number FWA00001331
Health conditions studied
1
Description of health condition studied Lung injury in sulfur mustard victims ICD-10 code
J68.4, J68
ICD-10 code description
Chronic respiratory conditions due to chemicals, gases, fumes and vapours, Other respiratory conditions due to chemicals, gases, fumes and vapours
Primary outcomes
1
Description Quality of life Timepoint
In enrolment stage and 6 months after the first cell injection
Method of measurement St. George's questionnaire form
Secondary outcomes
1
Description
Spirometry factors Timepoint
Befor each cell injection and 3 and 6 months after the first cel injection
Method of measurement spirometry
2
Description
Repair and inflammation factors of lung Timepoint
In enrolment stage and 3 and 6 months after the first cell injection
Method of measurement ELISA method
3
Description HRCT findings Timepoint
In enrolment stage and months after the first cell injection
3 Method of measurement
HRCT imaging
Intervention groups
1
Description
Drug: Placenta Placenta mesenchymal stem cell Dosage:
100 million cells per patient frequency: 4 times Duration:
15 days interval Injection method: vein injection Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center Shariati Hospital
Full name of responsible person Farzad Parvizpour
Street address
Shariati Hospital, Kargar Shomali Avenue, Tehran, Iran
City Tehran
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Veterans Medical Science and Engineering Research Centre
Full name of responsible person Mohamad Reza Soroush
Street address
No. 17, Farokh street, Moghadam Ardabili Street, Tehran, Iran
City Tehran Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Veterans Medical Science and Engineering Research Centre
Proportion provided by this source Public or private sector
empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding
empty
2 Sponsor
Name of organization / entity Iranian Stem Cell Council Full name of responsible person
Amir Ali Hamidieh Street address
Ladan alley, north sheikh Bahaie street, Mola sadra Street, Vanak Square, Tehran, Iran
City Tehran Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source Iranian Stem Cell Council
Proportion provided by this source Public or private sector
empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Farzad Parvizpour Position
Student
Other areas of specialty/work Street address
Central Lab, Shariati Hospital, Kargar Shomali Avenue, Tehran, Iran
City Tehran Postal code Phone
+98 21 8490 2172 Fax
f-parvizpour@razi.tums.ac.ir Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity Tehran university of medical sciences Full name of responsible person
4 Mohamad Vasei
Position Pathologist
Other areas of specialty/work Street address
Central lab, Shariati Hospital, Kargar Shomali Avenue, Tehran, Iran
City Tehran Postal code Phone
+98 21 8490 2172 Fax
mvasei@tums.ac.ir Web page address
Person responsible for updating data
Contact
Name of organization / entity Tehran University of Medical Sciences Full name of responsible person
Farzad Parvizpour Position
Student
Other areas of specialty/work Street address
Central lab, Shariati Hospital, Kargar Shomali Avenue, Tehran, Iran
City Tehran Postal code Phone
+98 21 8490 2172 Fax
f-parvizpour@razi.tums.ac.ir Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
