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

Institute of Cell Therapy

Status and phase: Unknown; Phase 2; Phase 1

Conditions: COVID-19 Pneumonia

Treatments: Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells; Device: Оxygen therapy; Drug: Hormones; Drug: Antibiotics; Drug: Anticoagulant Therapy

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04461925

#4/24.04.2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental group

Experimental group

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".

Treatment:

Drug: Anticoagulant Therapy

Drug: Antibiotics

Device: Оxygen therapy

Drug: Hormones

Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells

Control Group

Active Comparator group

Description:

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

Treatment:

Drug: Anticoagulant Therapy

Drug: Antibiotics

Device: Оxygen therapy

Drug: Hormones