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

COVID-19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04461925
• Other study ID #: #4/24.04.2020
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2, 2020
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: Institute of Cell Therapy
• Contact: Peter Nemtinov, MD
• Phone: +380442079207
• Email: nemtinov[@]stemcellclinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: May 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Intervention

Procedure:
• Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
i/v infusions

Drug:
• Antibiotics
per os
• Hormones
a moderate amount of dexamethasone i/v
• Anticoagulant Therapy
Sub-Q

Device:
• ?xygen therapy
?xygen therapy, mechanical ventilation and other supportive therapies

Locations

Country	Name	City	State
Ukraine	Institute of Cell Therapy	Kyiv

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cell Therapy	Kyiv City Clinical Hospital # 4

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in length of hospital stay	Length of Hospital Stay	up to 28 days
Primary	Changes in mortality rate	Marker for efficacy of treatment	up to 28 days
Secondary	Changes of ?-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
Secondary	Evaluation of Pneumonia Improvement	CT assessment of pulmonary lesions and lung tissue changes	At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Secondary	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
Secondary	Peripheral blood count recovery time	Degree of infection	At baseline, Day 1, Week 1, Week 2, Week 4, Week 8