<?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>IRCT20100718004409N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-04</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Mesenchymal stem cell in rotator cuff tear</public_title>
      <acronym></acronym>
      <scientific_title>The evaluation of effectiveness of mesenchymal stem cell derived from autologous adipose tissue compared to platelet rich plasma on pain and functionality of the patients with total tear of shoulder rotator cuff tendons (The second phase of a clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81157</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is base on block randomization. The 30 participants divided in  five blocks, each includes six. Three patients will take PRP and three patients will take stem cells in each group. The allocation of each one in each block is based on opening the envelops that determine type of intervention, Blinding description: Analyzer of the data is blinded to the intervention groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Full tear of shoulder rotator cuff tendon.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, 20 to 30 cc of fat is collected via liposuction in sterile conditions from the abdomen and flank areas of the patient and sent to the hospital's Motahari Clean Room laboratory for preparation. Flow cytometry tests are performed, and CD markers are checked. After the mesenchymal cells are prepared (2 to 3 months after the process begins), the sample will be sent to the sports medicine department of Rasoul Akram Hospital. At the same time, 1 cc of the solution containing the prepared cells will be injected into the torn tendon under ultrasound guidance. Intervention 2: Control group: For preparing Platelet Rich Plasma, 35 cc of venous blood will be drawn from the patients and placed in a centrifuge. The separated plasma from the first centrifugation for 10 minutes at 1600 Revolutions Per Minute (RPM) will be drawn in the tubes, and the second centrifugation will last for 6 minutes at 3200 RPM. Then, 3 cc from the end of each tube, after removing the upper plasma, will be drawn into a syringe. The injection will be performed under ultrasound guidance into the tear tendon.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The plan will be design after starting the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports Medicine Department , 8 th floor , Rasoul Akram Hospital , Niayesh Street , Satarkhan Street , Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2446</telephone>
        <email>Parisanejati@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Parisa Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports medicine department, Rasoul Akram hospital, Niayesh Avenue, Satarkhan street,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2446</telephone>
        <email>parisanejati@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Chronic shoulder pain (lasting over three months)
Confirmed complete tear of at least on tendon in shoulder MRI
At least positive five clinical shoulder tests including Neer, Hawkins, Jobe, extension lag, drop arm, resisted external and internal rotation
Age over 30 years</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Active malignancy or history of malignancy in the last 5 years in any area of the body
Calcific tendinitis
Adhesive capsulitis
History of receiving biological factor treatments in the past six months
Partial tears of the rotator cuff tendons
Emergency surgical indications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rotator cuff tear or rupture, not specified as traumatic</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: First, 20 to 30 cc of fat is collected via liposuction in sterile conditions from the abdomen and flank areas of the patient and sent to the hospital's Motahari Clean Room laboratory for preparation. Flow cytometry tests are performed, and CD markers are checked. After the mesenchymal cells are prepared (2 to 3 months after the process begins), the sample will be sent to the sports medicine department of Rasoul Akram Hospital. At the same time, 1 cc of the solution containing the prepared cells will be injected into the torn tendon under ultrasound guidance.</i_keyword>
      <i_keyword>Control group: For preparing Platelet Rich Plasma, 35 cc of venous blood will be drawn from the patients and placed in a centrifuge. The separated plasma from the first centrifugation for 10 minutes at 1600 Revolutions Per Minute (RPM) will be drawn in the tubes, and the second centrifugation will last for 6 minutes at 3200 RPM. Then, 3 cc from the end of each tube, after removing the upper plasma, will be drawn into a syringe. The injection will be performed under ultrasound guidance into the tear tendon.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and 1, 3, 6 months after injection. Method of measurement: Visual Analogue Scale Score.</prim_outcome>
      <prim_outcome>Tendon tear repair. Timepoint: Before intervention, 6 months after injection. Method of measurement: Magnetic Resonance Imaging.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Joint range of motion. Timepoint: Before intervention and 1, 3, 6 months after injection. Method of measurement: Hand held goniometry.</sec_outcome>
      <sec_outcome>Muscle strength. Timepoint: Before intervention and 1, 3, 6 months after injection. Method of measurement: Muscle strength testing scale on 1-5.</sec_outcome>
      <sec_outcome>Functionality. Timepoint: Before intervention and 1, 3, 6 months after injection. Method of measurement: Western Ontario Rotator Cuff and Disabilities of the Arm, Shoulder and Hand.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-22</approval_date>
        <contact_name>Ethic committee of Iran university of medical sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Near the Milad Tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
