Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs
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| ClinicalTrials.gov Identifier: NCT04461925 |
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Recruitment Status :
Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 Pneumonia | Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells Drug: Antibiotics Drug: Hormones Drug: Anticoagulant Therapy Device: Оxygen therapy | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 2, 2020 |
| Estimated Primary Completion Date : | May 2, 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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".
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Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
i/v infusions
Other Name: P-MMSCs Drug: Antibiotics per os
Other Name: ceftriaxone and azithromycin capsules Drug: Hormones a moderate amount of dexamethasone i/v
Other Name: dexamethasone Drug: Anticoagulant Therapy Sub-Q
Other Name: Еnoxaparin Device: Оxygen therapy Оxygen therapy, mechanical ventilation and other supportive therapies
Other Name: Оxygen insufflation |
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Active Comparator: Control Group
Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
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Drug: Antibiotics
per os
Other Name: ceftriaxone and azithromycin capsules Drug: Hormones a moderate amount of dexamethasone i/v
Other Name: dexamethasone Drug: Anticoagulant Therapy Sub-Q
Other Name: Еnoxaparin Device: Оxygen therapy Оxygen therapy, mechanical ventilation and other supportive therapies
Other Name: Оxygen insufflation |
- Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio. [ Time Frame: 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 [ Time Frame: up to 28 days ]Length of Hospital Stay
- Changes in mortality rate [ Time Frame: up to 28 days ]Marker for efficacy of treatment
- Changes of С-reactive protein (CRP, mg/L) [ Time Frame: 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.
- Evaluation of Pneumonia Improvement [ Time Frame: 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.) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Indirect response to lung function
- Peripheral blood count recovery time [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Degree of infection
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461925
| Contact: Peter Nemtinov, MD | +380442079207 | nemtinov@stemcellclinic.com | |
| Contact: Alina Ustymenko, PhD | +380442079207 | ustimenko@stemcellclinic.com |
| Ukraine | |
| Institute of Cell Therapy | Recruiting |
| Kyiv, Ukraine, 04073 | |
| Contact: Peter Nemtinov, MD +380442079207 nemtinov@stemcellclinic.com | |
| Contact: Alina Ustymenko, PhD +380442079207 ustimenko@stemcellclinic.com | |
| Principal Investigator: Alexey Chibisov, MD | |
| Study Director: | Peter Nemtinov, MD | Institute of Cell Therapy |
| Responsible Party: | Institute of Cell Therapy |
| ClinicalTrials.gov Identifier: | NCT04461925 |
| Other Study ID Numbers: |
#4/24.04.2020 |
| First Posted: | July 8, 2020 Key Record Dates |
| Last Update Posted: | July 8, 2020 |
| Last Verified: | June 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Placenta-derived MMSCs i/v infusions |
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Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Anti-Bacterial Agents Azithromycin Ceftriaxone Dexamethasone Enoxaparin Anticoagulants Hormones Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Molecular Mechanisms of Pharmacological Action Anti-Infective Agents Fibrinolytic Agents Fibrin Modulating Agents |