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Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs

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ClinicalTrials.gov Identifier: NCT04461925
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
Kyiv City Clinical Hospital # 4
Information provided by (Responsible Party):
Institute of Cell Therapy

Tracking Information
First Submitted Date  ICMJE July 1, 2020
First Posted Date  ICMJE July 8, 2020
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE May 2, 2020
Estimated Primary Completion Date May 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
  • Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio. [ Time Frame: up to 28 days ]
    Improvement of pulmonary function. Arterial oxygen tension PaO2 (in mmHg)/fractional inspired oxygen FiO2 (expressed as a fraction, not a percentage), most conveniently the P/F ratio. The normal P/F ratio is ~ 400-500 mmHg (~55-65 kPa). P/F ratio <300mmHg - sign of Acute Respiratory Distress Syndrome (ARDS)
  • Changes in length of hospital stay [ Time Frame: up to 28 days ]
    Length of Hospital Stay
  • Changes in mortality rate [ Time Frame: up to 28 days ]
    Marker for efficacy of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
  • Changes of С-reactive protein (CRP, mg/L) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]
    Infection biomarker. Serum CRP levels can be used for early diagnosis of pneumonia, patients with severe pneumonia had high CRP levels.
  • Evaluation of Pneumonia Improvement [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]
    CT assessment of pulmonary lesions and lung tissue changes
  • Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]
    Indirect response to lung function
  • Peripheral blood count recovery time [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]
    Degree of infection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs
Official Title  ICMJE Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic Multipotent Mesenchymal Stem Cells of the Placenta and Umbilical Cord
Brief Summary Assessment of the clinical effects of infusions of cryopreserved allogeneic multipotent mesenchymal stem cells of the placenta and umbilical cord for COVID-19 patients with acute respiratory distress syndrome.
Detailed Description

Currently, cell-based therapy and especially stem cell therapy has become a promising therapeutic field, in which many see opportunities to cure incurable diseases. Severe respiratory consequences of the COVID-19, the disease caused by the novel SARS-CoV-2 coronavirus, have prompted urgent need for novel therapies.

Cell-based approaches, primarily using mesenchymal stem cells (MSCs), have demonstrated safety and efficacy in patients with the acute respiratory distress syndrome (ARDS) - common manifestation of cytokine storms, and the cause of death in many COVID-19 patients.

Mesenchymal stem cells are a powerful immunomodulator, they secrete many anti-inflammatory biologically active substances (cytokines) that reduce the inflammatory process in the lungs. Also mesenchymal stem cells secrete numerous growth factors that contribute to the recovery of not only the affected lung tissue but also other organs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental: stem cells therapy + treatment in according with approved by Ukrainian Health Ministry COVID-19 clinical protocol Experimental Group 1: Subjects with severe COVID-19 pneumonia shall be received three infusions of cryopreserved allogeneic P-MMSCs (1 million cells/kg body weight) at 2-days intervals: Day "1", Day "4", Day "7".

Control Group: treatment in according with approved by Ukrainian MoH COVID-19 clinical protocol.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE
  • Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
    i/v infusions
    Other Name: P-MMSCs
  • Drug: Antibiotics
    per os
    Other Name: ceftriaxone and azithromycin capsules
  • Drug: Hormones
    a moderate amount of dexamethasone i/v
    Other Name: dexamethasone
  • Drug: Anticoagulant Therapy
    Sub-Q
    Other Name: Еnoxaparin
  • Device: Оxygen therapy
    Оxygen therapy, mechanical ventilation and other supportive therapies
    Other Name: Оxygen insufflation
Study Arms  ICMJE
  • Experimental: Experimental group
    On the basis conventional symptomatic treatment and supportive therapy, P-MMSCs were given at 1 million cells/kg body weight/ time, once every 3 days for a total of 3 times: Day "1", Day "4", Day "7".
    Interventions:
    • Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
    • Drug: Antibiotics
    • Drug: Hormones
    • Drug: Anticoagulant Therapy
    • Device: Оxygen therapy
  • Active Comparator: Control Group
    Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
    Interventions:
    • Drug: Antibiotics
    • Drug: Hormones
    • Drug: Anticoagulant Therapy
    • Device: Оxygen therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date May 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, aged at 18 years (including) - 75 years old.
  • Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source.
  • Pneumonia that is judged by X-ray imaging.

In accordance with any one of the following:

  • dyspnea (RR ≥ 30 times / min);
  • finger oxygen saturation ≤ 93% in resting state;
  • arterial oxygen partial pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300MMHG (if possible);
  • invasive ventilation< 48 h.

Exclusion Criteria:

  • Male or female, aged at <18 years and > 75 years old.
  • Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures.
  • Patients with malignant tumor, other serious systemic diseases and psychosis.
  • Patients who are participating in other clinical trials.
  • Inability to provide informed consent or to comply with test requirements.
  • Co-Infection of HIV, syphilis.
  • Invasive ventilation > 48 h.
  • Combined with other organ failure (need organ support).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Nemtinov, MD +380442079207 nemtinov@stemcellclinic.com
Contact: Alina Ustymenko, PhD +380442079207 ustimenko@stemcellclinic.com
Listed Location Countries  ICMJE Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04461925
Other Study ID Numbers  ICMJE #4/24.04.2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute of Cell Therapy
Study Sponsor  ICMJE Institute of Cell Therapy
Collaborators  ICMJE Kyiv City Clinical Hospital # 4
Investigators  ICMJE
Study Director: Peter Nemtinov, MD Institute of Cell Therapy
PRS Account Institute of Cell Therapy
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP