<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20091127002778N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-10</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of fat-derived stem cells in treatment of   multiple sclerosis</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>The effect of autologous adipose-derived mesenchymal stem cells transplantation in the treatment of  multiple sclerosis in Secondary Progressive phase</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2617</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data including video, self-reported documents and specific participant data sets can be share

When:
Availability start one month after publishing article

To whom:
Researchers and academic institutions

Conditions:
If researchers and academic institutions need files for more research and scientific queries, are permitted to analysis in related to  targeted purposes

Where to obtain:
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

How to obtain:
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

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahmoud Mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BouAli Research Institute, Ferdowsi Square, BouAli Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9196773117</zip>
        <telephone>+98 51 7112 6111</telephone>
        <email>MahmoudiM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahmoud Mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BouAli Research Institute, Ferdowsi Square., BuAli Square.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 1882 3255</telephone>
        <email>mahmoudim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35-G37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Demyelinating diseases of the central nervous system, multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of clinical scores. Timepoint: baseline, 6 and 9 months after Adipose-Tissue MSCs transplantation. Method of measurement: clinical observation by neurologist.</sec_outcome>
      <sec_outcome>Assessment of neurological function. Timepoint: baseline, 6 and 9 months after After-Tissue MSCs transplantation. Method of measurement: Magnetic resonance imaging (MRI).</sec_outcome>
      <sec_outcome>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.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-20</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ghoreishi building, daneshgah street, next to hoveizeh cinema Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
