Evaluation of safety and efficacy of allogeneic adipose-derived mesenchymal stem cell administration in Bronchiolitis Obliterans Syndrome (BOS) after allogeneic hematopoietic stem cell transplantation.
1) Evaluation of mesenchymal stem cell administration's safety in patients with bronchiolitis obliterans syndrome after hematopoietic stem cell transplantation.
2) Evaluation of the effectiveness of mesenchymal stem cell administration in patients with bronchiolitis obliterans syndrome after hematopoietic stem cell transplantation.
Design
Single-arm non-randomized clinical trial ( a pilot study).
Settings and conduct
1) Patients selection.
2) laboratory and pulmonary function tests for evaluation of bronchiolitis obliterans.
3) obtaining consent forms from patients' guardians.
4) manufacture of mesenchymal stem cells from adipose tissue.
5) administration of mesenchymal stem cells.
6) patients follow up and evaluations.
7) Record and publish data.
Participants/Inclusion and exclusion criteria
Patients under 16 years, transplantation has been done over the past year, FEV1<70% in spirometry, corticosteroid-resistant patients, absence of other concomitant infections.
Intervention groups
Intravenous injection of mesenchymal stem cells 1 million per kg for each individual patient.
Main outcome variables
Safety and efficacy of mesenchymal stem cell administration in patients with bronchiolitis obliterans.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201202049568N2
Registration date:2021-02-22, 1399/12/04
Registration timing:registered_while_recruiting
Last update:2021-02-22, 1399/12/04
Update count:0
Registration date
2021-02-22, 1399/12/04
Registrant information
Name
Rashin Mohseni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8444
Email address
rashin_mohseni@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
2020-12-21, 1399/10/01
Actual recruitment end date
2022-08-23, 1401/06/01
Trial completion date
2022-08-23, 1401/06/01
Scientific title
Evaluation of safety and efficacy of allogeneic adipose-derived mesenchymal stem cell administration in Bronchiolitis Obliterans Syndrome (BOS) after allogeneic hematopoietic stem cell transplantation.
Public title
Safety and efficacy of Mesenchymal Stem Cell administration in Bronchiolitis Obliterans Syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age below 16 years
Allogeneic hematopoietic stem cell transplantation (HSCT) over the past year
Forced Expiratory Volume in one second (FEV1) < 70 % (based on Pulmonary Function Test)
Diagnosis of BOS in end-stage phase with the history and clinical evaluation by a pediatric pulmonologist, and the presence of air-trapping or small airway involvement in high-resolution computed tomography (HRCT)
Absence of concomitant infections
Irresponsible to full-dose corticosteroids
Give the informed consent by the patients' legal guardians
Exclusion criteria:
Suspicion to any bacterial or viral pneumonia
CMV, VZV, HSV and/or fungal pneumonia
Haploidentical and/or T-cell deplete transplantation
Prior history of allergy or sensitivity to drugs
Relapse or progression of underlying malignancy
Age
From 1 month old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Actual sample size reached:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Pilot study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical science
Street address
e.g. Children medical centre., Dr Gharib Ave., Keshavarz Blvd., Tehran., Iran.
Before intervention and then 1,3,6 months after intervention.
Method of measurement
Pulmonary Function Test (Spirometry)
2
Description
FEV1/FVC ratio
Timepoint
Before intervention and then 1,3,6 months after intervention.
Method of measurement
Pulmonary Function Test (Spirometry)
Secondary outcomes
1
Description
Fractional exhaled nitric oxide (FeNO)
Timepoint
Before intervention and then 1,3,6 months after intervention.
Method of measurement
FeNO test
Intervention groups
1
Description
Intervention group: mesenchymal stem cells from the donors' adipose tissue will be extracted and then cultured in the laboratory. Final products will be injected with a dosage of 1 million per kg intravenously to the patients. All the patients will be hospitalized for 24 hours for further observation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's medical centre
Full name of responsible person
Amirali hamidieh
Street address
Children's medical centre., Gharib avenue., Keshavarz Blvd., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Fax
+98 21 6147 9000
Email
rashin_mohseni@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Poorsina st, Ghods st, Enghelab st. Tehran. Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 4605 3334
Fax
+98 21 4605 3334
Email
resdeputy@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
98-3-421-46134
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
28
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
2
Sponsor
Name of organization / entity
Council for Development of Stem Cell Sciences and Technologies
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Council for Development of Stem Cell Sciences and Technologies
Proportion provided by this source
28
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
3
Sponsor
Name of organization / entity
Omid charity
Full name of responsible person
Alireza Daliri
Street address
No 313., North Jamalzadeh., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6643 0886
Email
info@omid-charity.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Omid charity
Proportion provided by this source
44
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rashin Mohseni
Position
PhD in Applied Cell Science
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Pediatric Cell Therapy Research Center, Children's Medical Center Hospital, Gharib Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8444
Fax
Email
rashin_mohseni@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rashin Mohseni
Position
Ph.D. in Applied Cell Science
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Pediatric Cell Therapy Research Center, Children's Medical Center Hospital, Gharib Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8444
Fax
Email
rashin_mohseni@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rashin Mohseni
Position
Ph.D. in Applied Cell Science
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Pediatric Cell Therapy Research Center, Children's Medical Center Hospital, Gharib Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 8444
Fax
Email
rashin_mohseni@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data regarding the primary and secondary outcomes without any identifiable personal data will be shared.
When the data will become available and for how long
Six months after the publication of the results of this study
To whom data/document is available
Investigators in academic institutions.
Under which criteria data/document could be used
Medical doctors or scientists who are conducting studies in the same subject including mesenchymal stem cell therapy or bronchiolitis obliterans.
From where data/document is obtainable
The data that support the findings of this study will be available on request from the corresponding author. The data will not be publicly available due to privacy and ethical considerations.
What processes are involved for a request to access data/document
The data that support the findings of this study will be available on request from the corresponding author. The data will not be publicly available due to privacy and ethical considerations.