<?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>IRCT20160809029275N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-30</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>stem cell therapy in Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Evolution of Allogenic Mesenchymal stem cell- derived Umbilical cord  transplantation for ARDS patients infected with COVID19.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization. 
Eligible patients randomly and without considering a specific factor are divided into two groups: intervention and control.In this method, the random number table is used .So that people with individual codes are allocated in a 
group and people with couple codes are allocated in the other group.This method of randomization is performed to remove bias, Blinding description: No information will be provided to clinical caregivers and evaluators about which group got the cell and which one has not taken a cell.This method of blinding is performed to remove bias.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Covid-19 disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group receiving mesenchymal stem cells. In this group, patients in 3 times (1, 3 and 6 days) are received 1 million Umbilical core-derived MSCc/BW by intravenous injection ( Through the catheter and the Central vein and from the superior vena cava vein ). Also, in addition to cell therapy,Other common treatments will be given to patients according to the physician's supervision.Mesenchymal  Stem cells had an ISCT standard and were given from  a healthy donor. Blood samples were given from patients on days 0, 2, and 7, as well as 14 days after the second injection and patients will follow for 20 days (in terms of clinical and immunological parameters).It should be noted that of all patients at the beginning of the study conscious consent form will be received. Intervention 2: Control group: Receiving common therapies (without stem cell). In this group, patients are received other common treatments including antiviral drugs and etc In accordance with the physician's opinion and do not receive stem cells.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyad Jalil Tavakol Afshari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali square, Bu-Ali Science and Technology Park</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9196773117</zip>
        <telephone>+98 51 3711 2610</telephone>
        <email>Tavakolaj@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyad Jalil Tavakol Afshari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali square, Bu-Ali Science and Technology Park</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9196773117</zip>
        <telephone>+98 51 3711 2610</telephone>
        <email>Tavakolaj@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Covid-19 patient with acute respirstory infectious symptoms and  severe lung involvement
Pulmonary compliance more than 40
Age category 18-70 years
PI02/FIo2 between 100 - 300</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Covid-19 patient with Sepsis
Pregnancy
The presence of malignancy or other underlying diseases
Patient with age conditions outside the range of 18-70 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>RA01.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe Acute Respiratory Syndrome coronavirus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group receiving mesenchymal stem cells. In this group, patients in 3 times (1, 3 and 6 days) are received 1 million Umbilical core-derived MSCc/BW by intravenous injection ( Through the catheter and the Central vein and from the superior vena cava vein ). Also, in addition to cell therapy,Other common treatments will be given to patients according to the physician's supervision.Mesenchymal  Stem cells had an ISCT standard and were given from  a healthy donor. Blood samples were given from patients on days 0, 2, and 7, as well as 14 days after the second injection and patients will follow for 20 days (in terms of clinical and immunological parameters).It should be noted that of all patients at the beginning of the study conscious consent form will be received.</i_keyword>
      <i_keyword>Control group: Receiving common therapies (without stem cell). In this group, patients are received other common treatments including antiviral drugs and etc In accordance with the physician's opinion and do not receive stem cells.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory symptoms and pulmonary function in patients. Timepoint: In onset of study and days 2, 7 and 14 after the second injection. Method of measurement: Using  CT scan image , physical examination ,  Oxygen saturation Percentage.</prim_outcome>
      <prim_outcome>Evaluation of IFN-γ,IL4,TGF-β,IL1-β , IL-6 and TNF-a cytokine levels in patients blood. Timepoint: In onset of study and days 2, 7 and 14 after the second injection. Method of measurement: Using Elisa kits.</prim_outcome>
      <prim_outcome>Cell markers and  populations. Timepoint: In onset of study and days 2, 7 and 14 after the second injection. Method of measurement: Using Flow cytometery technique.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Parnia stem cell Knowledge-based company</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_name>Parnia stem cell Knowledge-based company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-23</approval_date>
        <contact_name>Regional Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave, Qoreishi Building,Vice chancellor for research and technology Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
