Official Title
Exploratory Clinical Study to Assess the Efficacy of NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia
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), a protective enzyme against lung damage. In addition,
the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for
the host cell entry and spread. Coronaviruses can be deadly, in large part because they cause
"cytokine storms." These storms result from imbalances between pro-inflammatory and
anti-inflammatory proteins called cytokines, which can cause extreme inflammation and
respiratory complications. Respiratory distress kills hundreds of thousands of people each
year worldwide, and hundreds of clinical trials are testing drugs to treat it.

MSCs have been widely used in cell-based therapy, from basic research to clinical trials
Safety and effectiveness have been clearly documented in many clinical trials, especially in
the immune-mediated inflammatory diseases.

NestaCell® is a mesenchymal stem cell therapy produced by Cellavita and proved to be safe in
previous clinical trials.

The aim of this study is assess the efficacy of NestCell® as an add-on therapy to standard
treatment to treat patients with severe COVID-19 pneumonia. .

Patients included will be randomized to receive 2x10^7 cells (20 million cells) on days 1, 3,
5 and 7.

COVID-19 Pneumonia

Biological: NestaCell®

A dose of 2x10^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects.
Other Name: Mesenchymal Stem Cell

Biological: Placebo

Matching Placebo will be administered IV on days 1, 3, 5 and 7 in all subjects.

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

1. Patients with autoimmune diseases in the past or screening;

2. 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;

3. Known or self-reported HIV or syphilis infected persons;

4. Have participated in stem cell clinical research;

5. Pregnant or lactating women or those who have fertility plans in the past year;

6. The estimated life cycle is less than 48 hours;

7. Other conditions that the researcher thinks are not suitable for participating in the

8. Shock

9. Continuous use of immunosuppressive agents or organ transplants in the past 6 months;

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A

Hospital Vera Cruz
Campinas, São Paulo, Brazil

Hospital de Barueri
São Paulo, Brazil

São Paulo, Brazil

São Paulo, Brazil

Florentino de Araujo Cardoso Filho, Principal Investigator
Hospital Vera Cruz

Azidus Brasil
NCT Number
MeSH Terms