<?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>IRCT20200426047213N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-14</date_registration>
      <primary_sponsor>Tehran Islamic Azad university of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of umbilical cord Mesenchymal Stem Cells on patients with neuromuscular disorders</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of Efficacy of umbilical cord derived mesenchymal Stem Cells transplantation on movement improvement in patients with neuromuscular disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47545</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients are divided into 4 groups of 30 patients (15 for Test group and 15 for control patients).The first group of patients with Duchenne and Becker muscular dystrophy based on genetic testing, the second group of neuropathic patients such as Spinal Muscular Atrophy and Charcot-Marie-Thoth disease based on genetic testing, the third group of patients with other types of muscular dystrophy such as Limb girdle Muscular Dystrophy and Congenital muscular dystrophy Based on genetic testing, the fourth group are other inherited myopathies such as congenital myopathy and congenital myasthenic syndrome, Randomization description: In order to randomly assign to the two groups of test and control, the block random division method with four blocks was used. In this way, the letter A was assigned to the test group and the letter B to the control group.
In four blocks with letters A and B, the six modes AABB, BBAA, ABAB, BABA, ABBA, BAAB were written on separate sheets and thrown inside a container and accidentally removed one of these sheets from the container. And the composition written on it was noted and again "that sheet was thrown into the container."
Because the sample size in this study was 30 patients, this operation was repeated eight times, and each time the composition written on each sheet was written in the sequence of the composition written on the previous sheet. Then, one letter from one to thirty letters was assigned to each of the letters in order, and each letter was placed in an envelope and the number was written on the envelope. Each time the disease was selected, one of the envelopes was opened in order of the number written on the envelope, and it was determined that the patient should be in the test or control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Dystrophinopathy(Duchenne muscular dystrophy, Becker muscular dystrophy). Condition 2: Spinal muscular atrophy. Condition 3: other Myopathy (Congenital myopathy, Congenital myasthenic syndrome). Condition 4: Charcot-Marie-Tooth).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In intervention group or test group the transplantation or injection of mesenchymal stem cell will be done. In this study the site of transplantation is in operation room of Farhikhtegan subspecialty hospital. Before the stem cell injection, the patient needs to be hospitalized for one day. For each patient, four injections are given at the first injection, two weeks later, one month later, and again three months intervals. 3 million per kilogram body weight mesenchymal stem cell are transplanted into the patient's weak muscles under sedation conditions and under ultrasound guidance. After the umbilical cord mesenchymal cell injection, the patient is hospitalized and monitored for 24 hours. Intervention 2: Control group: For each patient in Test group, there is a patient with same genetic mutation in control group. There is no intervention in control group. After determined intervention the clinical feature of these two group will be compared.</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:
After 12 months we will publish the analysis of datas

When:
After 12 months we will publish the analysis of datas

To whom:
All interested researchers

Conditions:
After 12 months we will publish the analysis of datas

Where to obtain:
Mohammadkazem Bakhshandeh

How to obtain:
Official request from research department

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Kazem Bakhshandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. MohammadKazem Bakhshandeh, Unit 6, Second floor, Mehr Afarin Doctors' Building, End of Morshedi Dead End, In Front of IranMehr Hospital, After Zafar St., Shariati St., Theran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1913776638</zip>
        <telephone>+98 21 2640 0779</telephone>
        <email>drbakhshandeh.com@gmail.com</email>
        <affiliation>Tehran Islamic Azad university of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Kazem Bakhshandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. MohammadKazem Bakhshandeh, Unit 6, Second floor, Mehr Afarin Doctors' Building, End of Morshedi Dead End, In Front of IranMehr Hospital, After Zafar St., Shariati St., Theran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1913776638</zip>
        <telephone>+98 21 2640 0779</telephone>
        <email>drbakhshandeh.com@gmail.com</email>
        <affiliation>Tehran Islamic Azad university of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Genetic confirmed patients with Dystrophinopathy(Duchenne muscular dystrophy, Becker muscular dystrophy)
Genetic confirmed patients with Neuropathy(Spinal muscular atrophy, Charcot-Marie-Tooth)
Genetic confirmed patients with other Muscular dystrophy(Limb girdle muscular dystrophy, Congenital muscular dystrophy)
Genetic confirmed patients with other Myopathy (Congenital myopathy, Congenital myasthenic syndrome)</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with cancer
Patients with chromosomal defects
Patients with HIV, HCV, HBV, HTLV1,2
Dissatisfaction for entering the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G71.0</hc_code>
      <hc_code>G12</hc_code>
      <hc_code>G71.2</hc_code>
      <hc_code>G60.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Muscular dystrophy</hc_keyword>
      <hc_keyword>Spinal muscular atrophy and related syndromes</hc_keyword>
      <hc_keyword>Congenital myopathies</hc_keyword>
      <hc_keyword>Hereditary motor and sensory neuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In intervention group or test group the transplantation or injection of mesenchymal stem cell will be done. In this study the site of transplantation is in operation room of Farhikhtegan subspecialty hospital. Before the stem cell injection, the patient needs to be hospitalized for one day. For each patient, four injections are given at the first injection, two weeks later, one month later, and again three months intervals. 3 million per kilogram body weight mesenchymal stem cell are transplanted into the patient's weak muscles under sedation conditions and under ultrasound guidance. After the umbilical cord mesenchymal cell injection, the patient is hospitalized and monitored for 24 hours.</i_keyword>
      <i_keyword>Control group: For each patient in Test group, there is a patient with same genetic mutation in control group. There is no intervention in control group. After determined intervention the clinical feature of these two group will be compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Muscle power. Timepoint: Before study, 6 and 9 and 12 months after Mesenchymal stem cell transplantation. Method of measurement: Walking distance in 6 minutes and muscular force examination.</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>Tehran Islamic Azad university of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-02</approval_date>
        <contact_name>Research ethics committee of Tehran Islamic Azad university of Medical Sciences</contact_name>
        <contact_address>Dr. MohammadKazem Bakhshandeh, Unit 6, Second floor, Mehr Afarin Doctors' Building, End of Morshedi Dead End,  In Front of IranMehr Hospital, After Zafar St., Shariati St., Theran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
