<?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>IRCT2013050813267N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-06</date_registration>
      <primary_sponsor>Shahid Sadoughi Yazd University Of Medical Sciences, Vice Chancellor for Research</primary_sponsor>
      <public_title>Studying the effect of bone marrow mesenchymal stem cell injection into the subarachnoid space on improvement and reduction of complications in spinal cord injured patients</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of bone marrow mesenchymal stem cell injection into the subarachnoid space on improvement and reduction of complications in spinal cord injured patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13181</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Spinal Cord Injury.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group, at first bone marrow aspiration (10ml) will be done and mesenchymal stem cells will be collected using centrifuge and Ficoll solvent. Cells will be cultured and after proliferation they will be collected by trypsination and microbial, quality and quantity analysis will be done on them.  Collected cells with the quantity of 10-20 million cells will be solved in 5ml distilled water, and will be injected slowly (5 minutes) to sub arachnoid space of patient using lumbar puncture technique by anesthesiologist in operating room and in sterile conditions. Each patients will have 3 injections with near to 1 month interval between them. Intervention 2: In control group just vehicle of cells (distilled water) with the same volume of intervention group (5ml) will be injected to the sub arachnoid space of patients. Injecting solvent will be injected slowly (5 minutes) and by anesthesiologist in the operating room and in sterile conditions. Each patient in this group will receive 3 injections by one month interval between them. Bone Marrow aspiration will not perform in this group but just the action of bone marrow aspiration will be simulated in the operating room for them.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Hobobati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Shahid Sadoughi Yazd University Of Medical Sciences, School Of Medicine</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173143</zip>
        <telephone>+98 35 1820 3410</telephone>
        <email>hh1358@gmail.com</email>
        <affiliation>Shahid Sadoughi Yazd University Of Medical Sciences, Yazd, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farshad Homayouni Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Shohadaye Gomnam Boulevard, Shahid Sadoughi Yazd University Of Medical Sciences</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1820 3411</telephone>
        <email>f_homayounim@yahoo.com</email>
        <affiliation>Shahid Sadoughi Yazd University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: filling the questionnaire by patient and his/her family; age 13-60; no more than 3 months passed from injury date, no history of cancer in patient and his family; no history to other chronic disorder; no other acute disease at present; self control on breathing; no contribution in the other studies; no convulsion and fever; no infectious diseases in patient like AIDS and hepatitis, and meningitis.&#13;
Exclusion criteria: patient request; occurrence of fever and convulsion after cell therapy, occurrence of any other complication; infection, instability of patient's health conditions ; worsening of the patient's disease.</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T09.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury Of Spinal Cord, Level Unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group, at first bone marrow aspiration (10ml) will be done and mesenchymal stem cells will be collected using centrifuge and Ficoll solvent. Cells will be cultured and after proliferation they will be collected by trypsination and microbial, quality and quantity analysis will be done on them.  Collected cells with the quantity of 10-20 million cells will be solved in 5ml distilled water, and will be injected slowly (5 minutes) to sub arachnoid space of patient using lumbar puncture technique by anesthesiologist in operating room and in sterile conditions. Each patients will have 3 injections with near to 1 month interval between them.</i_keyword>
      <i_keyword>In control group just vehicle of cells (distilled water) with the same volume of intervention group (5ml) will be injected to the sub arachnoid space of patients. Injecting solvent will be injected slowly (5 minutes) and by anesthesiologist in the operating room and in sterile conditions. Each patient in this group will receive 3 injections by one month interval between them. Bone Marrow aspiration will not perform in this group but just the action of bone marrow aspiration will be simulated in the operating room for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of Generation of Ectopic Tissue Such as Tumor After Stem Cell Therapy. Timepoint: Three months after third injection. Method of measurement: MRI; Physical Examination; Biochemical Tests About Presence of Ectopic Tissue or Tumor in Patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improvement In Somatic Sensation And Control Of Bladder , And Motor Function Improvements. Timepoint: 1 Month. Method of measurement: Physical Examination.</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>Shahid Sadoughi Yazd University Of Medical Sciences, Vice Chancellor for Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-14</approval_date>
        <contact_name>Iranian Ministry Of Health Ethic Commitee</contact_name>
        <contact_address>Tehran, Azady Boulevard Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
