Status:
UNKNOWN
Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs
Lead Sponsor:
Institute of Cell Therapy
Collaborating Sponsors:
Kyiv City Clinical Hospital # 4
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04461925
Start Date
May 2 2020
End Date
December 1 2021
Last Update
July 8 2020
Active Locations (1)
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1
Institute of Cell Therapy
Kyiv, Ukraine, 04073