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| Name | Class |
|---|---|
| Kyiv City Clinical Hospital # 4 | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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". |
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| Control Group | Active Comparator | Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells | Procedure | i/v infusions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 28 days |
| Changes in length of hospital stay | Length of Hospital Stay | up to 28 days |
| Changes in mortality rate | Marker for efficacy of treatment | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 |
| Evaluation of Pneumonia Improvement |
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Inclusion Criteria:
In accordance with any one of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Nemtinov, MD | Contact | +380442079207 | nemtinov@stemcellclinic.com | |
| Alina Ustymenko, PhD | Contact | +380442079207 | ustimenko@stemcellclinic.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Nemtinov, MD | Institute of Cell Therapy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cell Therapy | Recruiting | Kyiv | 04073 | Ukraine |
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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.
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| Antibiotics | Drug | per os |
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| Hormones | Drug | a moderate amount of dexamethasone i/v |
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| Anticoagulant Therapy | Drug | Sub-Q |
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| Оxygen therapy | Device | Оxygen therapy, mechanical ventilation and other supportive therapies |
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CT assessment of pulmonary lesions and lung tissue changes |
| At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 |
| Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.) | Indirect response to lung function | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 |
| Peripheral blood count recovery time | Degree of infection | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 |
| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D002443 | Ceftriaxone |
| D017963 | Azithromycin |
| D006728 | Hormones |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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