Protocol summary

Summary
1-Aim: Multiple sclerosis (MS) is an autoimmune disease characterize by demyelinating plaque in the central nervous system. The disease has no cure and no recognized definite cause yet. Impaired CD4+CD25+FoxP3+ Treg cells are the possible cause. The available therapies are mostly immunosuppressive disease modifying agents. Rapamycin is an immunosuppressive agent with and tolerable side effects. The aim of the present clinical trial is to evaluate the therapeutic effects of rapamycin on the patients with MS. 2-Design: simple sampling method is used for patients. Eight patients were selected. 3- In this study, 8 patients with MS will be treated with rapamycin (2 mg/day) for six months and before and after the therapy the following parameters will be studied. Number of CD4+CD25+FoxP3+ Treg, FoxP3 expression rate Th1,2 and 17 cytokine levels, Number and size of the plaques 4- Patients/Inclusion/exclusion Inclusion Relapsing- Remitting MS, MRI records that proved the existence of demyelination, 0-6 expanded disability status scale (EDSS), lack of response to β interferon or glatiramer acetate, stopping β interferon or glatiramer acetate one month before the experimentation . Exclusion criteria: Primary progressive MS, history of immunosuppressive therapy, side effects of the drug, steroid therapy in the last one month, any sign of infection and cancer, cardiovascular and hematological disorders, high serum cholesterol and using medication for it, history of hepatic cirrhosis or other liver diseases that require treatment, history of C and B hepatitis, active CMV infection, renal diseases which require treatment, active lung diseases, diabetes, hyperthyroidism, infection with HIV, tuberculosis, history of alcohol misuse during last 6 months, phobia from MRI (Claustrophobia) and pregnant and lactating women 5- Trial: Six months of administration of rapamycin 2 mg per day 6- Main variables: Number of CD4+CD25+FoxP3+ Treg, FoxP3 expression rate, Number and size of the plaques

General information

Acronym
Effects of Rapamycin on MS
IRCT registration information
IRCT registration number: IRCT2012092510936N1
Registration date: 2015-01-08, 1393/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-08, 1393/10/18
Registrant information
Name
Bahram Bagherpour
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3661 4502
Email address
bagherpour@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
This study was financially supported by Vice-chancellor of Research and Technology, Isfahan University of Medical Sciences, Isfahan, Iran (a fifth of the budget), Mr Ali Feiz (Three-fifths of the budget) and the rest, a fifth, was provided by the first author.
Expected recruitment start date
2012-11-09, 1391/08/19
Expected recruitment end date
2013-05-09, 1392/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Rapamycin on the gene expression of FoxP3 and GARP in CD4+CD25+FoxP3 Treg cells and evaluation of Tregs number and function in Multiple Sclerosis
Public title
Effects of Rapamycin on multiple Sclerosis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Relapsing- Remitting MS; MRI records that proved the existence of demyelination; 0-6 expanded disability status scale (EDSS); lack of response to β interferon or glatiramer acetate; stopping β interferon or glatiramer acetate one month before the experimentation . Exclusion criteria: primary progressive MS; history of immunosuppressive therapy; side effects of the drug; steroid therapy in the last one month; any sign of infection and cancer; cardiovascular and hematological disorders; high serum cholesterol and using medication for it; history of hepatic cirrhosis or other liver diseases that require treatment; history of C and B hepatitis; active CMV infection; renal diseases which require treatment; active lung diseases, diabetes, hyperthyroidism, infection with HIV, tuberculosis; history of alcohol misuse during last 6 months; phobia from MRI (claustrophobia) and pregnant and lactating women.
Age
From 24 years old to 27 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 8
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
Ethical committee, Isfahan University of Medical Sciences
Street address
Ethical committee, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2012-05-02, 1391/02/13
Ethics committee reference number
391223

Health conditions studied

1

Description of health condition studied
relapsing remitting multiple sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Reduction in plaque area and number, variation in the expesion of FOXP3 gene
Timepoint
Before and 6 months after the therapy with rapamyin
Method of measurement
MRI, real-time PCR

Secondary outcomes

1

Description
Th1, 2 and 17 Cytokine variation
Timepoint
Before and 6 months after therapy with rapamycin
Method of measurement
ELISA

Intervention groups

1

Description
FDA approved drug (Rapamycin) administrated to the patients, 2 mg daily for 6 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Educational Hospital
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor of Research and Technology, Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Vice-chancellor of Research and Technology, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research and Technology, Isfahan University of Medical Sciences, Isfahan, Iran
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
Charity
Full name of responsible person
Mr. Ali Feiz
Street address
Seyed Al Shohada Hospital, Khayam St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Charity
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

3

Sponsor
Name of organization / entity
The researcher
Full name of responsible person
Bahram Bagherpour
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The researcher
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
Department of Genetics and Molecular Biology, School of Medicine, Isfahan University of Medical Scie
Full name of responsible person
Mansour Salehi
Position
Ph.D. Staff member
Other areas of specialty/work
Street address
Department of Genetics and Molecular Biology, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 2486
Fax
Email
m_salehi@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Full name of responsible person
Vahid Shayghannejad
Position
MpH, Neurology
Other areas of specialty/work
Street address
Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3233 0099
Fax
Email
shaygannejad@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Genetics and Molecular Biology, School of Medicine, Isfahan University of Medical Scie
Full name of responsible person
Bahram Bagherpour
Position
PhD candidate
Other areas of specialty/work
Street address
Department of Genetics and Molecular Biology, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran
City
Isfahan
Postal code
Phone
00
Fax
Email
bagherpour@resident.mui.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
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