<?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>IRCT20160110025930N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-29</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Safety investigation of simultaneous injection of olfactory ensheathing cells and mesenchymal stem cells in treatment of spinal cord injury</public_title>
      <acronym></acronym>
      <scientific_title>Safety assessment for co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in complete human spinal cord injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32536</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: 10 enrolled patients of the study are divided into two groups: the main treatment group is transplanted with autologous olfactory ensheathing cells and mesenchymal stem cells and there is no cell therapy intervention in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spinal Cord Injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with complete spinal cord injury who are co-transplanted with autologous Olfactory Ensheathing Cells (OECs) (isolated from olfactory mucosa) and Mesenchymal Stem Cells (MSCs) (isolated from bone marrow aspirate) which is injected into lesioned spinal cord in a ratio of 50:50 and cell dose of about 20-30 million. Intervention 2: Control group: Patients with complete spinal cord injury who are under routine cares and no extra action is performed on 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Homa Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Jalal AleAhmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4507</telephone>
        <email>homa.zamani@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoud Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Jalal AleAhmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4508</telephone>
        <email>soleim_m@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Traumatic thoracic spinal cord injury
Complete loss of sensory and motor function below the injury (ASIA Category A)
Time from injury at least 6 months (chronic phase)
No mental disturbances in patient
Good patient motivation and cooperation and confirmation of written informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Coexisting lesion of the nervous system
Transection lesions of the spinal cord due to sharp objects
Spinal stenosis in parts other than the damaged area
Muscle atrophy or joint ossification
Severe systemic disease such as neoplasm and diabetes
Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G95.20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified cord compression</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with complete spinal cord injury who are co-transplanted with autologous Olfactory Ensheathing Cells (OECs) (isolated from olfactory mucosa) and Mesenchymal Stem Cells (MSCs) (isolated from bone marrow aspirate) which is injected into lesioned spinal cord in a ratio of 50:50 and cell dose of about 20-30 million.</i_keyword>
      <i_keyword>Control group: Patients with complete spinal cord injury who are under routine cares and no extra action is performed on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Type and amount of observed side effects due to the co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in patients with complete spinal cord injury in order to safety assessment for this intervention. Timepoint: 1, 6, and 12 months post cell transplantation. Method of measurement: 1-General physical assessments and laboratory tests like blood, serum, and urine analysis 2- Spinal radiological assessments with MRI imaging.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-17</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Jalal AleAhmad Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
