Evaluation of placenta drove mesenchymal stem cells injection's safety in SPMS patients.
Design
An open-label phase 1 clinical trial to assess safety and
Feasibility of PLMSCs on 5 patients with SPMS
Settings and conduct
Placenta-derived mesenchymal stem cells are about 1× 106 MSC / Kg by intravenous injection with Rituximab (500-1000mg i.v) in Sina and Shariati hospital
Participants/Inclusion and exclusion criteria
The inclusion criteria: Patients with SPMS, Age between
18–45 years, Disease duration of more than 2 and less than 15 years, Patients who are taking Rituximab drugs.
The Exclusion criteria: Pregnant patients, patients with other systemic problems, Patients with positive results from screening tests (HBV, HCV, HIV, HTLV).
Intervention groups
Placenta-derived mesenchymal stem cells are about 1× 106 MSC / Kg by intravenous injection in one patient
Main outcome variables
Safety and side effects of MSCs transplantation on neurophysiological functions, clinical symptoms, and immunological procedures.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051576N1
Registration date:2021-07-25, 1400/05/03
Registration timing:retrospective
Last update:2021-07-25, 1400/05/03
Update count:0
Registration date
2021-07-25, 1400/05/03
Registrant information
Name
Ameneh Shokati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4305 2000
Email address
amenesh113@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
2021-06-11, 1400/03/21
Actual recruitment end date
2021-06-24, 1400/04/03
Trial completion date
2022-09-22, 1401/06/31
Scientific title
Cell therapy using human placenta-derived mesenchymal stem cells(PLMSCs) in patients with Secondary progressive-MS(SPMS): clinical trial phase I
Public title
The effect of MSCs transplantation in the treatment of SPMS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with SPMS
Age between18–45 years
Disease duration of 2 - 16 years
Patients who are taking Rituximab drugs
Exclusion criteria:
Pregnant patients
Patients with positive results from screening tests (HBV, HCV, HIV, HTLV)
Patients with other systemic problems.
Age
From 17 years old to 45 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
Actual sample size reached:
5
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
Iran National committee for Ethics in Biomedical research
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
2021-05-31, 1400/03/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.197
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Safety and side effects of PLMSCs transplantation in terms of pain
Timepoint
baseline, 1,3,6 and 9 months after PLMSCs injection
Method of measurement
self-reported of patients
2
Description
Safety and side effects of high dose PLMSCs transplantation in terms of hypersensitivity.
Timepoint
baseline, 1,3,6 and 9 months after PLMSCs injection
Method of measurement
clinical observation
Secondary outcomes
1
Description
Safety of stem cell transplantation in terms of infection
Timepoint
baseline, 1,3 months after MSCs injection
Method of measurement
CBC, LP
2
Description
Severity of clinical scores
Timepoint
baseline, 1,3,6 and 9 months after MSCs transplantation
Method of measurement
clinical observation by neurologist
3
Description
assessment of neurological function
Timepoint
baseline, 6 and 9 months after After MSCs transplantation
Method of measurement
Magnetic resonance imaging (MRI)
4
Description
assessment of Biomarkers concentrations in peripheral blood of patients
Timepoint
baseline,1,3, 6 months after SCs transplantation
Method of measurement
Flowcytometery
Intervention groups
1
Description
Intervention group: mesenchymal stem cells(MSCs) in a amountof 1×106 MSC/Kg with Rituximab (500-1000mg i.v)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Abdolreaza Naser Moghaddasi,Jafar Ai
Street address
Sina Hospital, Hassan Abad Sq., Imam Khomeini St., Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Email
amenesh113@gmail.com
Web page address
http://sinahospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr َMohammad Ali Sahraian
Street address
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6670 6142
Email
msahrai@sina.tums.ac.ir
Web page address
Grant name
Grant code / Reference number
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 2000
Email
amenesh113@gmail.cm
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Abdorreza Naser Moghadasi,DrJafar Ai
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Appleid cell sciences
Street address
Iran,Tehran,Hasan Abad Sq, Sina Hospital
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8571
Email
amenesh113@gmail.com
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
Appleid cell sciences
Street address
Tehran Province, Tehran, Eastern side of Tehran University، Italy St, No. 88
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 8800 9153
Email
amenesh113@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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available