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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

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.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells Drug: Antibiotics Drug: Hormones Drug: Anticoagulant Therapy Device: Оxygen therapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic Multipotent Mesenchymal Stem Cells of the Placenta and Umbilical Cord
Actual Study Start Date : May 2, 2020
Estimated Primary Completion Date : May 2, 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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".
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

Active Comparator: Control Group
Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
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




Primary Outcome Measures :
  1. 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)

  2. Changes in length of hospital stay [ Time Frame: up to 28 days ]
    Length of Hospital Stay

  3. Changes in mortality rate [ Time Frame: up to 28 days ]
    Marker for efficacy of treatment


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. Peripheral blood count recovery time [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]
    Degree of infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461925


Contacts
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Contact: Peter Nemtinov, MD +380442079207 nemtinov@stemcellclinic.com
Contact: Alina Ustymenko, PhD +380442079207 ustimenko@stemcellclinic.com

Locations
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Ukraine
Institute of Cell Therapy Recruiting
Kyiv, Ukraine, 04073
Contact: Peter Nemtinov, MD    +380442079207    nemtinov@stemcellclinic.com   
Contact: Alina Ustymenko, PhD    +380442079207    ustimenko@stemcellclinic.com   
Principal Investigator: Alexey Chibisov, MD         
Sponsors and Collaborators
Institute of Cell Therapy
Kyiv City Clinical Hospital # 4
Investigators
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Study Director: Peter Nemtinov, MD Institute of Cell Therapy
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Responsible Party: Institute of Cell Therapy
ClinicalTrials.gov Identifier: NCT04461925    
Other Study ID Numbers: #4/24.04.2020
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Cell Therapy:
Placenta-derived MMSCs
i/v infusions
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Azithromycin
Ceftriaxone
Dexamethasone
Enoxaparin
Anticoagulants
Hormones
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Fibrinolytic Agents
Fibrin Modulating Agents