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

July 7, 2020 updated by: Institute of Cell Therapy

Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic Multipotent Mesenchymal Stem Cells of the Placenta and Umbilical Cord

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Kyiv, Ukraine, 04073
        • Recruiting
        • Institute of Cell Therapy
        • Contact:
        • Principal Investigator:
          • Alexey Chibisov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • P-MMSCs
Drug: Antibiotics
per os
Other Names:
  • ceftriaxone and azithromycin capsules
Drug: Hormones
a moderate amount of dexamethasone i/v
Other Names:
  • dexamethasone
Drug: Anticoagulant Therapy
Sub-Q
Other Names:
  • Еnoxaparin
Device: Оxygen therapy
Оxygen therapy, mechanical ventilation and other supportive therapies
Other Names:
  • 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 Names:
  • ceftriaxone and azithromycin capsules
Drug: Hormones
a moderate amount of dexamethasone i/v
Other Names:
  • dexamethasone
Drug: Anticoagulant Therapy
Sub-Q
Other Names:
  • Еnoxaparin
Device: Оxygen therapy
Оxygen therapy, mechanical ventilation and other supportive therapies
Other Names:
  • Оxygen insufflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 28 days
Changes in length of hospital stay
Time Frame: up to 28 days
Length of Hospital Stay
up to 28 days
Changes in mortality rate
Time Frame: up to 28 days
Marker for efficacy of treatment
up to 28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cell Therapy

Collaborators

Kyiv City Clinical Hospital # 4

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2020

Primary Completion (Anticipated)

May 2, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4/24.04.2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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