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

Primary Purpose

COVID-19 Pneumonia

Status
Unknown status
Phase
Phase 1
Locations
Ukraine
Study Type
Interventional
Intervention
Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
Antibiotics
Hormones
Anticoagulant Therapy
Оxygen therapy
Sponsored by
Institute of Cell Therapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring Placenta-derived MMSCs, i/v infusions

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Institute of Cell TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

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".

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

Outcomes

Primary Outcome Measures

Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio.
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
Length of Hospital Stay
Changes in mortality rate
Marker for efficacy of treatment

Secondary Outcome Measures

Changes of С-reactive protein (CRP, mg/L)
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
CT assessment of pulmonary lesions and lung tissue changes
Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.)
Indirect response to lung function
Peripheral blood count recovery time
Degree of infection

Full Information

First Posted
July 1, 2020
Last Updated
July 7, 2020
Sponsor
Institute of Cell Therapy
Collaborators
Kyiv City Clinical Hospital # 4
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1. Study Identification

Unique Protocol Identification Number
NCT04461925
Brief Title
Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2020 (Actual)
Primary Completion Date
May 2, 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Cell Therapy
Collaborators
Kyiv City Clinical Hospital # 4

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
Placenta-derived MMSCs, i/v infusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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".
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
Intervention Type
Procedure
Intervention Name(s)
Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
Other Intervention Name(s)
P-MMSCs
Intervention Description
i/v infusions
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Other Intervention Name(s)
ceftriaxone and azithromycin capsules
Intervention Description
per os
Intervention Type
Drug
Intervention Name(s)
Hormones
Other Intervention Name(s)
dexamethasone
Intervention Description
a moderate amount of dexamethasone i/v
Intervention Type
Drug
Intervention Name(s)
Anticoagulant Therapy
Other Intervention Name(s)
Еnoxaparin
Intervention Description
Sub-Q
Intervention Type
Device
Intervention Name(s)
Оxygen therapy
Other Intervention Name(s)
Оxygen insufflation
Intervention Description
Оxygen therapy, mechanical ventilation and other supportive therapies
Primary Outcome Measure Information:
Title
Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio.
Description
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)
Time Frame
up to 28 days
Title
Changes in length of hospital stay
Description
Length of Hospital Stay
Time Frame
up to 28 days
Title
Changes in mortality rate
Description
Marker for efficacy of treatment
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Changes of С-reactive protein (CRP, mg/L)
Description
Infection biomarker. Serum CRP levels can be used for early diagnosis of pneumonia, patients with severe pneumonia had high CRP levels.
Time Frame
At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Title
Evaluation of Pneumonia Improvement
Description
CT assessment of pulmonary lesions and lung tissue changes
Time Frame
At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Title
Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.)
Description
Indirect response to lung function
Time Frame
At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Title
Peripheral blood count recovery time
Description
Degree of infection
Time Frame
At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Nemtinov, MD
Phone
+380442079207
Email
nemtinov@stemcellclinic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alina Ustymenko, PhD
Phone
+380442079207
Email
ustimenko@stemcellclinic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Nemtinov, MD
Organizational Affiliation
Institute of Cell Therapy
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Cell Therapy
City
Kyiv
ZIP/Postal Code
04073
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Nemtinov, MD
Phone
+380442079207
Email
nemtinov@stemcellclinic.com
First Name & Middle Initial & Last Name & Degree
Alina Ustymenko, PhD
Phone
+380442079207
Email
ustimenko@stemcellclinic.com
First Name & Middle Initial & Last Name & Degree
Alexey Chibisov, MD

12. IPD Sharing Statement

Learn more about this trial

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

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