<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04437823</url>
  </required_header>
  <id_info>
    <org_study_id>JB&amp;RSC-01</org_study_id>
    <nct_id>NCT04437823</nct_id>
  </id_info>
  <brief_title>Efficacy of Intravenous Infusions of Stem Cells in the Treatment of COVID-19 Patients</brief_title>
  <official_title>Efficacy of Intravenous Infusions of Stem Cells in the Treatment of COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinnah Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jinnah Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stem cell therapy has emerged as a revolutionary treatment for diseases that were considered&#xD;
      untreatable only a few years ago. Umbilical cord-derived mesenchymal stem cells (UCMSCs) have&#xD;
      been shown to repair damaged liver, kidney, heart, pancreas, skin, cartilage, and cornea in&#xD;
      animal models and several human trials. In addition to cellular replacement through&#xD;
      regeneration, UCMSCs mediate through paracrine signaling pathways resulting in immune&#xD;
      modulation. Clinical manifestations of coronavirus disease 2019 (COVID-19), are believed to&#xD;
      arise from septic shock and cytokine storm that cause acute respiratory dysfunction and acute&#xD;
      cardiac injury. There is presently no cure for the COVID-19 viral disease; however,&#xD;
      multi-treatment strategies are being examined. During the past two months, four reports were&#xD;
      published that suggest, mesenchymal stem cells (MSCs), owing to their powerful&#xD;
      immunomodulatory ability, may prevent the cytokine storm and thus reduce the COVID-19 related&#xD;
      morbidity. All studies reported that COVID-19 patients responded favorably to MSCs therapy.&#xD;
      These reports, taken together with the previous successes of stem cell therapy in animal&#xD;
      models, the investigators, a seven-institution consortium, propose to explore the efficacy of&#xD;
      UCMSC treatment in COVID-19 patients at Jinnah hospital, Lahore. The investigators propose to&#xD;
      administer UCMSCs in patients with acute pulmonary inflammation due to COVID-19 infection&#xD;
      with moderate to severe symptoms. In the first cohort of 15 patients, UCMSCs will be&#xD;
      administered with three intravenous infusions of 500,000 UCMSCs per Kg body weight each on&#xD;
      days 1, 3, and 5. The second group of five patients serving as control will only receive&#xD;
      standard treatment. During the 30-day post-infusion period, a battery of tests will be&#xD;
      performed to evaluate the safety and efficacy of the UCMSCs treatment. In parallel, the&#xD;
      investigators propose a comparative study to determine COVID-19 viral count by quantitative&#xD;
      real-time PCR and through viral coat protein ELISA, developed in the investigator advisor lab&#xD;
      (Dr. Tauseef Butt, Progenra Inc. Philadelphia, USA) with the ultimate objective to locally&#xD;
      developing a rapid diagnostic assay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Isolation and characterization of human umbilical cord-derived mesenchymal stem cells&#xD;
      (UCMSCs): Human umbilical cord tissues along with informed consent forms will be collected&#xD;
      from hepatitis B, C, and COVID-19 virus-negative women with healthy pregnancies during the&#xD;
      Cesarean Section surgery after completion of gestation period. The cord tissue will be&#xD;
      transported in sterile 1x phosphate-buffered saline (PBS) containing 200 units/ml penicillin&#xD;
      and 200 µg/ml streptomycin on ice. In the biosafety cabinet, the cord will be washed with 4-5&#xD;
      changes of sterile 1x PBS and placed in a Petri plate with 15 ml PBS. The cord will be gently&#xD;
      scraped with a surgical blade to remove any dead cells. A 9 cm umbilical cord will be cut&#xD;
      into three equal pieces and wash thoroughly to remove blood clots, umbilical cord arteries,&#xD;
      and veins. Segments will be washed three times with PBS and minced. The minced pieces will be&#xD;
      incubated in 17.5 ml of collagenase solution (201 U/ml collagenase type I in serum-free&#xD;
      DMEM-HG) in a 50 ml conical tube for ~3.5 hours in an incubator at 5% CO2, 95% humidity at&#xD;
      37⁰C. After ~3.5 hours, the digested lysate will pass through a strainer and will be diluted&#xD;
      three times with 1x PBS. Following centrifugation, the cells will be seeded into two 25 cm2&#xD;
      flasks and will be placed in an incubator at 5% CO2, 95% humidity at 37⁰C. The flasks will be&#xD;
      fed with fresh media (DMEM-HG supplemented with 20% FBS and 1% antibiotic solution) every&#xD;
      third day. At around day 18, cells will reach up to 85% confluency and will be transferred in&#xD;
      two 75 cm2 flasks with media replaced at alternate days. UCMSCs at P3 will be characterized&#xD;
      using different specific antibodies. Cells at P3 will be used for transplantation in&#xD;
      patients. Fifteen (15) subjects will be treated with three intravenous infusions (IV) of&#xD;
      500,000 UCMSCs per Kg body weight delivered via peripheral intravenous infusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Group 1 (15 subjects) Fifteen (15) subjects will be treated with three intravenous infusion (IV) of 5 x 10^5 (per Kg body weight) UCMSCs delivered via peripheral intravenous infusion on days 1, 3 and 5 besides the standard care (SOC).&#xD;
Group 2 (5 subjects) Five (5) subjects will be treated under SOC. From two subjects in group 1 will not be treated 24hrs apart. Patients will be randomized in a 1:3 ratio (SOC: UCMSC).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and efficacy assessment of infusion associated adverse events</measure>
    <time_frame>Day 01 to Day 30</time_frame>
    <description>Number of participants with significant side effects in stem cell treated group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chest Radiograph or Chest CT Scan</measure>
    <time_frame>Day 01 to Day 30</time_frame>
    <description>Assessment of Pneumonia improvement as a result of stem cell infusions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID-19 Quantitative Real Time PCR</measure>
    <time_frame>Day 01 to Day 30</time_frame>
    <description>Quantitative real-time PCR analysis for the evaluation of negative corona virus test results following stem cell treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sequential Organ Failure Assessment (SOFA) Score</measure>
    <time_frame>Day 01 to Day 30</time_frame>
    <description>Evaluation of organ function (Each organ system is assigned a value for 0 (normal) to 4 (highest degree of dysfunction))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of mortality</measure>
    <time_frame>Day 01 to Day 30</time_frame>
    <description>Number of all mortalities within 30 days post first infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Respiratory Changes</measure>
    <time_frame>Day 01 to Day 30</time_frame>
    <description>Examination of improvement in the physiology of lungs after treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>Group 1 : Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fifteen (15) subjects will be treated with three intravenous infusion (IV) of 5 x 10^5 UCMSCs per Kg body weight delivered via peripheral intravenous infusion on days 1, 3 and 5 besides the standard care (SOC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Five (5) subjects will be treated under Standard of Care (SOC) .</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Intravenous Infusions of Stem Cells</intervention_name>
    <description>Cultured stem cells will be injected at days 1, 3 and 5 intravenously. While patients will be monitored and evaluated for various hematological and organ functions at baseline (day 0) and days 1, 3, 5, 7, 14, 21 and 30</description>
    <arm_group_label>Group 1 : Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
          -  Male or female subjects age &gt;18 years at the time of signing the Informed Consent Form&#xD;
&#xD;
          -  Must have a clinical diagnosis of COVID-19, with at least one of clinical symptoms&#xD;
             (e.g., fever ≥38°C, fatigue, cough) and a positive result by the reverse-transcription&#xD;
             polymerase chain reaction (RT-PCR) testing or equivalent&#xD;
&#xD;
          -  Individuals with moderate to severe COVID-19 symptoms&#xD;
&#xD;
          -  Adequate venous access&#xD;
&#xD;
          -  For female patients only, willingness to use recommended birth control until 6 months&#xD;
             post-treatment&#xD;
&#xD;
          -  Must agree to comply with all study requirements and be willing to complete all study&#xD;
             visits&#xD;
&#xD;
          -  Need in-patient admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A female who is pregnant, nursing, or of child-bearing potential while not practicing&#xD;
             effective contraceptive methods. Female subjects must undergo a blood pregnancy test&#xD;
             at screening and prior to infusion.&#xD;
&#xD;
          -  Inability to perform any of the assessments required for endpoint analysis&#xD;
&#xD;
          -  Have known allergies to penicillin or streptomycin&#xD;
&#xD;
          -  Have a clinical history of malignancy within 3 years (i.e., subjects with prior&#xD;
             malignancy must be disease-free for 3 years), except curatively-treated basal cell&#xD;
             carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma, if&#xD;
             recurrence occurs; - History of drug abuse (illegal &quot;street&quot; drugs except for&#xD;
             marijuana, or prescription medications not being used appropriately for a pre-existing&#xD;
             medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented&#xD;
             medical, occupational, or legal problems arising from the use of alcohol or drugs&#xD;
             within the past 24 months&#xD;
&#xD;
          -  Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moazzam N Tarar, MBBS, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinnah Burn &amp; Reconstructive Surgery Center, Lahore</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azra Mehmood, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre of Excellence in Molecular Biology, Lahore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheikh Riazuddin, PhD</last_name>
    <phone>+9242935164422</phone>
    <email>riazuddin@aimrc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohsin Shahzad, PhD</last_name>
    <phone>+923218429448</phone>
    <email>riazuddin@aimrc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jinnah Hospital</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54550</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr.</citation>
    <PMID>32257537</PMID>
  </reference>
  <reference>
    <citation>Atluri S, Manchikanti L, Hirsch JA. Expanded Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) as a Therapeutic Strategy in Managing Critically Ill COVID-19 Patients: The Case for Compassionate Use. Pain Physician. 2020 Mar;23(2):E71-E83.</citation>
    <PMID>32214286</PMID>
  </reference>
  <reference>
    <citation>Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. No abstract available.</citation>
    <PMID>32194981</PMID>
  </reference>
  <reference>
    <citation>Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.</citation>
    <PMID>32169119</PMID>
  </reference>
  <reference>
    <citation>Riazuddin S et al.,. Book chapter: Stem cells for the repair of damaged skin and cartilage, in Book: Stem Cells - From Drug to Drug Discovery. Ed. by Haider, Khawaja Husnain; ISBN# 978-3-11-049376-4; March 2017</citation>
  </reference>
  <reference>
    <citation>Riazuddin S et al., Cell therapy for liver regeneration. In , (Eds.), Stem Cells - From Hype to Real Hope (pp. 130-145). Berlin, Boston: De Gruyter. https://doi.org/10.1515/9783110587043-007; Book DOI: https://doi.org/10.1515/9783110587043; Online ISBN: 9783110587043; © 2018 Walter de Gruyter GmbH, Berlin/Munich/Boston.</citation>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinnah Hospital</investigator_affiliation>
    <investigator_full_name>Prof. Sheikh Riazuddin</investigator_full_name>
    <investigator_title>Distinguished National Professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Stem Cells treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The report will be published and available online.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>At the end of completion of the study</ipd_time_frame>
    <ipd_access_criteria>Available online</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04437823
org study id: JB&RSC-01
nct id: NCT04437823
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Stem cell therapy has emerged as a revolutionary treatment for diseases that were considered
      untreatable only a few years ago. Umbilical cord-derived mesenchymal stem cells (UCMSCs) have
      been shown to repair damaged liver, kidney, heart, pancreas, skin, cartilage, and cornea in
      animal models and several human trials. In addition to cellular replacement through
      regeneration, UCMSCs mediate through paracrine signaling pathways resulting in immune
      modulation. Clinical manifestations of coronavirus disease 2019 (COVID-19), are believed to
      arise from septic shock and cytokine storm that cause acute respiratory dysfunction and acute
      cardiac injury. There is presently no cure for the COVID-19 viral disease; however,
      multi-treatment strategies are being examined. During the past two months, four reports were
      published that suggest, mesenchymal stem cells (MSCs), owing to their powerful
      immunomodulatory ability, may prevent the cytokine storm and thus reduce the COVID-19 related
      morbidity. All studies reported that COVID-19 patients responded favorably to MSCs therapy.
      These reports, taken together with the previous successes of stem cell therapy in animal
      models, the investigators, a seven-institution consortium, propose to explore the efficacy of
      UCMSC treatment in COVID-19 patients at Jinnah hospital, Lahore. The investigators propose to
      administer UCMSCs in patients with acute pulmonary inflammation due to COVID-19 infection
      with moderate to severe symptoms. In the first cohort of 15 patients, UCMSCs will be
      administered with three intravenous infusions of 500,000 UCMSCs per Kg body weight each on
      days 1, 3, and 5. The second group of five patients serving as control will only receive
      standard treatment. During the 30-day post-infusion period, a battery of tests will be
      performed to evaluate the safety and efficacy of the UCMSCs treatment. In parallel, the
      investigators propose a comparative study to determine COVID-19 viral count by quantitative
      real-time PCR and through viral coat protein ELISA, developed in the investigator advisor lab
      (Dr. Tauseef Butt, Progenra Inc. Philadelphia, USA) with the ultimate objective to locally
      developing a rapid diagnostic assay.
Isolation and characterization of human umbilical cord-derived mesenchymal stem cells
      (UCMSCs): Human umbilical cord tissues along with informed consent forms will be collected
      from hepatitis B, C, and COVID-19 virus-negative women with healthy pregnancies during the
      Cesarean Section surgery after completion of gestation period. The cord tissue will be
      transported in sterile 1x phosphate-buffered saline (PBS) containing 200 units/ml penicillin
      and 200 µg/ml streptomycin on ice. In the biosafety cabinet, the cord will be washed with 4-5
      changes of sterile 1x PBS and placed in a Petri plate with 15 ml PBS. The cord will be gently
      scraped with a surgical blade to remove any dead cells. A 9 cm umbilical cord will be cut
      into three equal pieces and wash thoroughly to remove blood clots, umbilical cord arteries,
      and veins. Segments will be washed three times with PBS and minced. The minced pieces will be
      incubated in 17.5 ml of collagenase solution (201 U/ml collagenase type I in serum-free
      DMEM-HG) in a 50 ml conical tube for ~3.5 hours in an incubator at 5% CO2, 95% humidity at
      37⁰C. After ~3.5 hours, the digested lysate will pass through a strainer and will be diluted
      three times with 1x PBS. Following centrifugation, the cells will be seeded into two 25 cm2
      flasks and will be placed in an incubator at 5% CO2, 95% humidity at 37⁰C. The flasks will be
      fed with fresh media (DMEM-HG supplemented with 20% FBS and 1% antibiotic solution) every
      third day. At around day 18, cells will reach up to 85% confluency and will be transferred in
      two 75 cm2 flasks with media replaced at alternate days. UCMSCs at P3 will be characterized
      using different specific antibodies. Cells at P3 will be used for transplantation in
      patients. Fifteen (15) subjects will be treated with three intravenous infusions (IV) of
      500,000 UCMSCs per Kg body weight delivered via peripheral intravenous infusion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group 1 (15 subjects) Fifteen (15) subjects will be treated with three intravenous infusion (IV) of 5 x 10^5 (per Kg body weight) UCMSCs delivered via peripheral intravenous infusion on days 1, 3 and 5 besides the standard care (SOC).
Group 2 (5 subjects) Five (5) subjects will be treated under SOC. From two subjects in group 1 will not be treated 24hrs apart. Patients will be randomized in a 1:3 ratio (SOC: UCMSC).
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and efficacy assessment of infusion associated adverse events
time frame: Day 01 to Day 30
description: Number of participants with significant side effects in stem cell treated group
measure: Chest Radiograph or Chest CT Scan
time frame: Day 01 to Day 30
description: Assessment of Pneumonia improvement as a result of stem cell infusions
measure: COVID-19 Quantitative Real Time PCR
time frame: Day 01 to Day 30
description: Quantitative real-time PCR analysis for the evaluation of negative corona virus test results following stem cell treatment
measure: Sequential Organ Failure Assessment (SOFA) Score
time frame: Day 01 to Day 30
description: Evaluation of organ function (Each organ system is assigned a value for 0 (normal) to 4 (highest degree of dysfunction))
measure: Rate of mortality
time frame: Day 01 to Day 30
description: Number of all mortalities within 30 days post first infusion
measure: Clinical Respiratory Changes
time frame: Day 01 to Day 30
description: Examination of improvement in the physiology of lungs after treatment
arm group label: Group 1 : Treatment
arm group type: Experimental
description: Fifteen (15) subjects will be treated with three intravenous infusion (IV) of 5 x 10^5 UCMSCs per Kg body weight delivered via peripheral intravenous infusion on days 1, 3 and 5 besides the standard care (SOC).
arm group label: Group 2: standard care
arm group type: No Intervention
description: Five (5) subjects will be treated under Standard of Care (SOC) .
intervention type: Biological
intervention name: Intravenous Infusions of Stem Cells
description: Cultured stem cells will be injected at days 1, 3 and 5 intravenously. While patients will be monitored and evaluated for various hematological and organ functions at baseline (day 0) and days 1, 3, 5, 7, 14, 21 and 30
arm group label: Group 1 : Treatment
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Moazzam N Tarar, MBBS, FCPS
role: Principal Investigator
affiliation: Jinnah Burn & Reconstructive Surgery Center, Lahore
last name: Azra Mehmood, PhD
role: Principal Investigator
affiliation: Centre of Excellence in Molecular Biology, Lahore
last name: Sheikh Riazuddin, PhD
phone: +9242935164422
email: riazuddin@aimrc.org
last name: Mohsin Shahzad, PhD
phone: +923218429448
email: riazuddin@aimrc.org
facility: 
status: Recruiting
country: Pakistan
citation: Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr.
PMID: 32257537
citation: Atluri S, Manchikanti L, Hirsch JA. Expanded Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) as a Therapeutic Strategy in Managing Critically Ill COVID-19 Patients: The Case for Compassionate Use. Pain Physician. 2020 Mar;23(2):E71-E83.
PMID: 32214286
citation: Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. No abstract available.
PMID: 32194981
citation: Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.
PMID: 32169119
citation: Riazuddin S et al.,. Book chapter: Stem cells for the repair of damaged skin and cartilage, in Book: Stem Cells - From Drug to Drug Discovery. Ed. by Haider, Khawaja Husnain; ISBN# 978-3-11-049376-4; March 2017
citation: Riazuddin S et al., Cell therapy for liver regeneration. In , (Eds.), Stem Cells - From Hype to Real Hope (pp. 130-145). Berlin, Boston: De Gruyter. https://doi.org/10.1515/9783110587043-007; Book DOI: https://doi.org/10.1515/9783110587043; Online ISBN: 9783110587043; © 2018 Walter de Gruyter GmbH, Berlin/Munich/Boston.
responsible party type: Principal Investigator
investigator affiliation: Jinnah Hospital
investigator full name: Prof. Sheikh Riazuddin
investigator title: Distinguished National Professor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: Yes
ipd description: The report will be published and available online.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: At the end of completion of the study
ipd access criteria: Available online