Status:
COMPLETED
NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
Cellavita Pesquisa Científica Ltda
Hospital Vera Cruz
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.
Detailed Description
The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel coronavirus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), ...
Eligibility Criteria
Inclusion
- 1\. Male or female, aged ≥ 18 years 2. Present a confirmed or pending diagnosis of COVID-19, but with tomographic and clinical signs strongly suggestive of SARS-CoV-2 infection (COVID-19), with pulmonary impairment greater than or equal to 50% and: i. Oxygen saturation \<95%; ii. CURB-65 rating ≥ a 4; d) Participants with a score on WHO ordinal scale that measures illness severity over time equal to 5 (Hospitalized with non-invasive ventilation or high-flow oxygen).
Exclusion
- Patients with autoimmune diseases in the past or screening;
- Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
- Known or self-reported HIV or syphilis infected persons;
- Have participated in stem cell clinical research;
- Pregnant or lactating women or those who have fertility plans in the past year;
- The estimated life cycle is less than 48 hours;
- Other conditions that the researcher thinks are not suitable for participating in the experiment.
- Shock
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04315987
Start Date
June 30 2020
End Date
February 28 2021
Last Update
October 28 2022
Active Locations (4)
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1
Hospital Vera Cruz
Campinas, São Paulo, Brazil
2
Hospital de Barueri
São Paulo, Brazil
3
IncCOR
São Paulo, Brazil
4
UNIFESP
São Paulo, Brazil