COVID-19 Pneumonia
Conditions
Keywords
Placenta-derived MMSCs, i/v infusions
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.
Interventions
PROCEDUREPlacenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
i/v infusions
DRUGAntibiotics
per os
DRUGHormones
a moderate amount of dexamethasone i/v
DRUGAnticoagulant Therapy
Sub-Q
DEVICEОxygen therapy
Оxygen therapy, mechanical ventilation and other supportive therapies
Sponsors
Kyiv City Clinical Hospital # 4
Institute of Cell Therapy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio. | 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) |
| Changes in length of hospital stay | up to 28 days | Length of Hospital Stay |
| Changes in mortality rate | up to 28 days | Marker for efficacy of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of С-reactive protein (CRP, mg/L) | 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. |
| Peripheral blood count recovery time | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | Degree of infection |
| Evaluation of Pneumonia Improvement | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | CT assessment of pulmonary lesions and lung tissue changes |
| Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.) | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | Indirect response to lung function |
Countries
Ukraine
Contacts
Primary ContactPeter Nemtinov, MD
Backup ContactAlina Ustymenko, PhD
Outcome results
None listed