Clinical trial NCT04461925: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: COVID-19 Pneumonia
Keywords: Placenta-derived MMSCs
i/v infusions
Lead sponsor: Institute of Cell Therapy
Sponsor class: INDUSTRY
Collaborators: name: Kyiv City Clinical Hospital # 4
First posted: 2020-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio.
timeFrame: up to 28 days
measure: Changes in length of hospital stay
timeFrame: up to 28 days
measure: Changes in mortality rate
timeFrame: up to 28 days
Secondary outcomes:
measure: Changes of С-reactive protein (CRP, mg/L)
timeFrame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
measure: Evaluation of Pneumonia Improvement
timeFrame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
measure: Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.)
timeFrame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
measure: Peripheral blood count recovery time
timeFrame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Institute of Cell Therapy
Study officials:
affiliation: Institute of Cell Therapy
name: Peter Nemtinov, MD
role: STUDY_DIRECTOR
References: