Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs
NCT ID: NCT04461925
Last Updated: 2020-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2020-05-02
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Control Group: treatment in according with approved by Ukrainian MoH COVID-19 clinical protocol.
TREATMENT
NONE
Study Groups
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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".
Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
i/v infusions
Antibiotics
per os
Hormones
a moderate amount of dexamethasone i/v
Anticoagulant Therapy
Sub-Q
Оxygen therapy
Оxygen therapy, mechanical ventilation and other supportive therapies
Control Group
Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
Antibiotics
per os
Hormones
a moderate amount of dexamethasone i/v
Anticoagulant Therapy
Sub-Q
Оxygen therapy
Оxygen therapy, mechanical ventilation and other supportive therapies
Interventions
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Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
i/v infusions
Antibiotics
per os
Hormones
a moderate amount of dexamethasone i/v
Anticoagulant Therapy
Sub-Q
Оxygen therapy
Оxygen therapy, mechanical ventilation and other supportive therapies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Kyiv City Clinical Hospital # 4
UNKNOWN
Institute of Cell Therapy
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Nemtinov, MD
Role: STUDY_DIRECTOR
Institute of Cell Therapy
Locations
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Institute of Cell Therapy
Kyiv, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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#4/24.04.2020
Identifier Type: -
Identifier Source: org_study_id
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