safety of hEnSCs injection in SPMS female patients.
Design
an open label phase 1 clinical trial to assess safety and Feasibility of hEnSCs on 10 female with SPMS
Settings and conduct
Patient recruitment are performed in Sina Hospital.. Endometrial tissue biopsy , hEnSCs isolation, characterization, and culture for IV injection are done and The injection of cells prepared is also done by a neurosurgeon at Sina hospital . Next we evaluate the effect of hEnSCs on patients by assessment of MRI scans on baseline, 6 and 9 months after transplantation.
Participants/Inclusion and exclusion criteria
The inclusion criteria:
Women with SPMS
Age between 18–45 years , EDSS less than 5.5, Disease duration of more than 2 and less than 15 years, Women who are taking Rituximab drugs
The Exclusion criteria:
Pregnant patients , patients with other systemic or endometriosis and other uterine problems ,Patients with positive results from screening tests (HBV,HCV,HIV,HTLV)
Intervention groups
The effect of hEnSCs on 10 female with SPMS
Main outcome variables
Efficacy of hEnSCs on neurophysiological functions , Improvement in clinical evaluations and immunological procedures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190711044175N1
Registration date:2019-12-25, 1398/10/04
Registration timing:registered_while_recruiting
Last update:2019-12-25, 1398/10/04
Update count:1
Registration date
2019-12-25, 1398/10/04
Registrant information
Name
Somayeh Ebrahimi-barough
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 9153
Email address
ebrahimi_s@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cell therapy using human endometrial stem cell(hEnSCs) in patients with Secondary progressive-MS(SPMS): Phase I clinical trial
Public title
The effect of hEnSCs transplantation in the treatment of SPMS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
(1)Women with SPMS who did not respond to their disease-modifying therapies .
(2) Age between 18–45 years
(3) EDSS less than 5.5
(4) Disease duration of 2 - 15 years..
(5) Women with at least one delivery
(6) Women who are taking Rituximab drugs
Exclusion criteria:
Women under the age of 18 and over 45 years
Pregnant patients
Patients with positive results from screening tests for hepatitis B and C, human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) were also excluded from the study.
Patients who had used cytotoxic agents or hormonal therapy within 3 months prior to the study .
Patients with endometriosis and other uterine problems
Age
From 18 years old to 45 years old
Gender
Female
Phase
1
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee for Biological Research of Tehran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-11-29, 1398/09/08
Ethics committee reference number
IR.TUMS.VCR.REC.1398.662
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system, multiple sclerosis
Primary outcomes
1
Description
Safety and side effects of hEnSCs transplantation in terms of pain
Timepoint
baseline, 1,3,6 and 9 months after hEnSCs injection
Method of measurement
self-reported of patients
2
Description
Safety and side effects of high dose hEnSCs transplantation in terms of hypersensivity
Timepoint
baseline, 1,3,6 and 9 months after hEnSCs injection
Method of measurement
clinical observation
3
Description
Safety of stem cell transplantation in terms of infection
Timepoint
baseline, 1,3,6 and 9 months after AT-MSCs injection
Method of measurement
CBC, LP
Secondary outcomes
1
Description
Severity of clinical scores
Timepoint
baseline, 1,3,6 and 9 months after hEnSCs transplantation
Method of measurement
clinical observation by neurologist
2
Description
assessment of neurological function
Timepoint
baseline, 1,3,6 and 9 months after After hEnSCs transplantation
Method of measurement
Magnetic resonance imaging (MRI)
3
Description
assessment of B cell markers CD19+CD20 percentage and MMP9 in peripheral blood of patients
Timepoint
baseline,1,3, 6 and 9 months after SCs transplantation
Method of measurement
Flowcytometery , eliza
Intervention groups
1
Description
Intervention group: endometrial Stem Cells in a amount of 5×106 MSC/Kg with Rituximab (500-1000mg i.v)
Category
Treatment - Drugs
2
Description
Control group: Rituximab (500-1000mg i.v) with placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
سمیه ابراهیمی باروق،عبدالرضا ناصر مقدسی
Street address
Imam Khomeini St., Hassan Abad Sq., Sina Hospital, Tehran - Iran
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
50
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
Tehran University of Medical Sciences
Full name of responsible person
Ameneh Shokati
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Applied cell sciences
Street address
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 4305 2113
Email
amenesh113@gmail.com
Web page address
http://satim.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Ebrahimi-Barough
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
No.88, keshavarz blvd, italia streat
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Fax
Email
ebrahimi_s@sina.tums.ac.ir
Web page address
http://satim.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ameneh Shokati
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Applied cell sciences
Street address
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 4305 2113
Email
amenesh113@gmail.com
Web page address
http://satim.tums.ac.ir/
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
All data including video, self-reported documents and specific participant data sets can be share
When the data will become available and for how long
Availability start one month after publishing article
To whom data/document is available
Researchers and academic institutions
Under which criteria data/document could be used
If researchers and academic institutions need files for more research and scientific queries, are permitted to analysis in related to targeted purposes
From where data/document is obtainable
Access to principle investigator is possible by respectively: Emial, Contact information, Attendance in the institute which principle investigator is engaged in.
Email: ebrahimi_s@sina.tums.ac.ir
Phone: +989125710837
Work phone:009843052113
Street address: tehran university of medical sciences
What processes are involved for a request to access data/document
If we ensure that researchers and academic institutions need files for more research and scientific queries, They will access into files up to two weeks