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The effect of autologous adipose-derived mesenchymal stem cells transplantation in the treatment of multiple sclerosis in Secondary Progressive phase

Protocol summary

Study aim
Main purpose was safety of high dose adipose-tissue MSCs in Secondary Progressive MS female patients Secondary purpose was efficacy of AT-MSC on neurophysiological functions, clinical evaluations and regulatory lymphocytes of patients
Design
we aim to design an open label phase 1/2 clinical trial to assess safety and efficacy of adipose-derived mesenchymal stem cells on10 female with secondary progressive phase of multiple sclerosis (SPMS).
Settings and conduct
10 female with secondary progressive phase of multiple sclerosis (SPMS) were selected from MS association center and refereed to Ghaem Hospital of Mashhad. Abdominal fat of patients was removed. After harvesting their adipose tissue mesenchymal stem cells (AT-MSCs) were expanded to reach to a range of 5×106 MSC/Kg. Then their expanded AT-MSCs were infused in 2 dosage during 2 injection space 7 days apart. Next we evaluate the effect of AT-MSCs on patients by assessment of MRI scans on baseline, 6 and 9 months after transplantation, EDSS and TCD4+CD25+FOXP3+CD127- population derived from peripheral blood on baseline, 2 weeks, 1, 3, 6 and 9 months after first injection. .All assessments are done in Ghaem Hospital of Mashhad.
Participants/Inclusion and exclusion criteria
inclusion criteria are female with secondary progressive phase of multiple sclerosis (SPMS) aged under 50 years, Expanded Disability Status Scale (EDDS) score 3 -6.5, Failure to response to the available disease modifying treatments exclusion criteria are Having relapses or using steroid drugs within the month prior to trial, History of malignancy, Acute or chronic infection, Immunodeficiency, Pregnancy, Lactating woman, Cardiac, renal or hepatic failure, Positive serology for HIV, Hepatitis B, Hepatitis C, Incapability for a biopsy of at least 50 grams of fat tissue, Treatment with any disease modifying treatment during the trial, unable to give written informed consent
Intervention groups
The effect of adipose tissue mesenchymal stem cells (AT-MSCs) on a group consist of 10 female with secondary progressive multiple sclerosis (SPMS)
Main outcome variables
Efficacy of adipose tissue mesenchymal stem cells (AT-MSCs) on neurophysiological functions identified in MRI scans, Improvement in clinical evaluations according to standard criteria and Improvement of immunological procedures by decreasing regulatory lymphocytes population.

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20091127002778N1
Registration date: 2018-01-10, 1396/10/20
Registration timing: registered_while_recruiting

Last update: 2018-01-10, 1396/10/20
Update count: 0
Registration date
2018-01-10, 1396/10/20
Registrant information
Name
Mahmoud Mahmoudi
Name of organization / entity
Immunology Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2611
Email address
mahmoudim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences, Mashhad, Iran
Expected recruitment start date
2016-08-15, 1395/05/25
Expected recruitment end date
2018-02-27, 1396/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of autologous adipose-derived mesenchymal stem cells transplantation in the treatment of multiple sclerosis in Secondary Progressive phase
Public title
The effect of fat-derived stem cells in treatment of multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with MS according to McDonald criteria Secondary Progressive MS according to neurologist comment and standard critria Expanded Disability Status Scale (EDDS) score 3 -6.5 Failure to response to the available disease modifying treatments age under 50 years female
Exclusion criteria:
Having relapses within the month prior to trial Using steroid drugs within the month prior to trial History of malignancy Acute or chronic infection Immunodeficiency Pregnancy Lactating woman Cardiac, renal or hepatic failure Positive serology for HIV, Hepatitis B, Hepatitis C Incapability for a biopsy of at least 50 grams of fat tissue Treatment with any disease modifying treatment during the trial Patients unable to give written informed consent
Age
To 50 years old
Gender
Female
Phase
1-2
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 Mashhad University of Medical Sciences
Street address
Ghoreishi building, daneshgah street, next to hoveizeh cinema
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Approval date
2015-08-20, 1394/05/29
Ethics committee reference number
ir.mums.rec.1394.633

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 high dose Adipose-Tissue MSCs transplantation in terms of pain
Timepoint
baseline, 1,3,6 and 9 months after AT-MSCs injection
Method of measurement
self-reported of patients

2

Description
Safety and side effects of high dose Adipose-Tissue MSCs transplantation in terms of hypersensivity
Timepoint
baseline, 1,3,6 and 9 months after AT-MSCs 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, 6 and 9 months after Adipose-Tissue MSCs transplantation
Method of measurement
clinical observation by neurologist

2

Description
assessment of neurological function
Timepoint
baseline, 6 and 9 months after After-Tissue MSCs transplantation
Method of measurement
Magnetic resonance imaging (MRI)

3

Description
assessment of Tregulatory CD4+CD25+FOXP3+ percentage and lack of CD127 in peripheral blood of patients
Timepoint
baseline,1,3, 6 and 9 months after AT-MSCs transplantation
Method of measurement
Flowcytometery

Intervention groups

1

Description
intervention:Adipose-Tissue Mesenchymal Stem Cells in a amount of 5×106 MSC/Kg, each dosage include 2.5×106 MSC/Kg into MS patients, 2 dosage during 2 injection space 7 days apart
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mahmoud Mahmoudi
Street address
BuAli Research Institute, Ferdowesi Square, BuAli Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 7112 6111
Fax
Email
MahmoudiM@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad, Vakilabad boulevard, Bahonar Street, School of Pharmacy, Pharmaceutical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 1882 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Mahmoudi
Position
Professor of Mashhad Immunology Department
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
BouAli Research Institute, Ferdowsi Square, BouAli Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 7112 6111
Fax
Email
MahmoudiM@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Mahmoudi
Position
professor of Mashhad Immunology Department
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
BouAli Research Institute, Ferdowsi Square., BuAli Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 1882 3255
Fax
Email
mahmoudim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Forouzan Yousefi
Position
Ph.D. student of Immunology
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
BuAli Research Institute, Ferdowesi Square, BuAli Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 7112 6111
Fax
Email
Forouzan.mania@gmail.com
Web page address

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, Fax, Attendance in the institute which principle investigator is engaged in. Email: MahmoudiM@mums.ac.ir Phone: +98 51 7112 6111 Mobile: +98 915 115 6304 Work phone:00985138022229 Street address: BouAli Research Institute, Ferdowsi Square, BouAli Square
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
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