<?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>IRCT20201202049568N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Safety and efficacy of Mesenchymal Stem Cell administration in Bronchiolitis Obliterans Syndrome.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of safety and efficacy of allogeneic adipose-derived mesenchymal stem cell administration in Bronchiolitis Obliterans Syndrome (BOS) after allogeneic hematopoietic stem cell transplantation.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53143</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Pilot study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>bronchiolitis obliterans.</hc_freetext>
      <i_freetext>Intervention group: mesenchymal stem cells from the donors' adipose tissue will be extracted and then cultured in the laboratory. Final products will be injected with a dosage of 1 million per kg intravenously to the patients. All the patients will be hospitalized for 24 hours for further observation..</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:
The data regarding the primary and secondary outcomes without any identifiable personal data will be shared.

When:
Six months after the publication of the results of this study

To whom:
Investigators in academic institutions.

Conditions:
Medical doctors or scientists who are conducting studies in the same subject including mesenchymal stem cell therapy or bronchiolitis obliterans.

Where to obtain:
The data that support the findings of this study will be available on request from the corresponding author. The data will not be publicly available due to privacy and ethical considerations.

How to obtain:
The data that support the findings of this study will be available on request from the corresponding author. The data will not be publicly available due to privacy and ethical considerations.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rashin Mohseni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Cell Therapy Research Center, Children's Medical Center Hospital, Gharib Ave, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733151</zip>
        <telephone>+98 21 6694 8444</telephone>
        <email>rashin_mohseni@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rashin Mohseni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Cell Therapy Research Center, Children's Medical Center Hospital, Gharib Ave, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733151</zip>
        <telephone>+98 21 6694 8444</telephone>
        <email>rashin_mohseni@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age below 16 years
Allogeneic hematopoietic  stem cell transplantation (HSCT) over the past year
Forced Expiratory Volume in one second (FEV1) &lt; 70 % (based on Pulmonary Function Test)
Diagnosis of BOS in end-stage phase  with the history and clinical evaluation by a pediatric pulmonologist, and the presence of air-trapping or small airway involvement in high-resolution computed tomography (HRCT)
Absence of concomitant infections
Irresponsible to full-dose corticosteroids
Give the informed consent by the patients' legal guardians</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suspicion to any bacterial or viral pneumonia
CMV, VZV, HSV and/or  fungal pneumonia
Haploidentical and/or T-cell deplete transplantation
Prior history of allergy or sensitivity to drugs
Relapse or progression of underlying malignancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J84.115</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory bronchiolitis interstitial lung disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: mesenchymal stem cells from the donors' adipose tissue will be extracted and then cultured in the laboratory. Final products will be injected with a dosage of 1 million per kg intravenously to the patients. All the patients will be hospitalized for 24 hours for further observation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Forced expiratory volume in one second (FEV1). Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: Pulmonary Function Test (Spirometry).</prim_outcome>
      <prim_outcome>FEV1/FVC ratio. Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: Pulmonary Function Test (Spirometry).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fractional exhaled nitric oxide (FeNO). Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: FeNO test.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Council for Development of Stem Cell Sciences and Technologies</sponsor_name>
      <sponsor_name>Omid charity</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
      <source_name>Council for Development of Stem Cell Sciences and Technologies</source_name>
      <source_name>Omid charity</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-05</approval_date>
        <contact_name>Ethics committee of Tehran university of medical science</contact_name>
        <contact_address>e.g. Children medical centre., Dr Gharib Ave., Keshavarz Blvd., Tehran., Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
