Phase II Clinical Study (pilot according to WHO).
Evaluation of the Efficacy and Safety of NestaCell® Mesenchymal Stem Cells in the treatment of hospitalized patients infected with the SARS-CoV-2 virus (COVID-19).
Worldwide publication and scientific data
Pre-Clinical Biodistribution Studies:
Behavior of NestaCell® product in vivo
Cells biodistribution capacity of NestaCell® product in vivo after intravenous administration. After 4 hours, the BLM signal of the marked cells was detected on the lung in 100% of the animals . The cells remained in the organ (lung) for up to 30 days.
G6 – No induction of 3-NPA with Administration of hIDPSC-Red-FLuc+
Initial date – Animal – 4 hours – 24 hours – 3 days – 7 days – 30 d
Bioluminescence images of cells marked with luciferase (Hidpsc-Red-Luc+) from animals of the C57 black lineage in prone position acquired by IVIS Lumina II (Xenogen Corp. CA, USA.)
Lung tissue optical microscopy images using the Fast Red and Prussian Blue coloration of G4 group, after 30 days.
Primary Efficacy Objective of the Study and its variable.
To evaluate the efficacy of advanced cellular therapy NestaCell® in promoting the reduction of the hospitalization time of COVID-19 patients on invasive mechanical ventilation.
The clinical status of the participants throughout the study will be assessed by the Ordinal Scale of Assessment of Clinical Evolution. Grades 6 and 7 of this scale correspond to invasive mechanical ventilation. The treatment groups will be compared regarding the average number of days spent in grades 6 or 7.
This Phase 2 clinical trial will be prospective, double-blind, randomized, parallel, interventional, multicentric and placebo-controlled.
Ninety participants will be included in the study. Participants will be randomized in a 1:1 ratio to the Test group: NestaCell® , or Control group: placebo, NestaCell® vehicle. Of the 90 participants, 45 will be randomized to the Test group (NestaCell®) and 45 to the Control group (Placebo). Thus, the groups listed below represent the groups in which participants may be included in the course of the study.
- Test Group: NestaCell®
- Control Group: Placebo: constituted by the investigational product vehicle.
Investigators and Main Research Sites:
Dr. Florentino Cardoso – Oncologist and Intensivist – Casa de Saúde de Campinas
Dr. Ricardo Diaz – Infectologist – Escola Paulista de Medicina (Unifesp)
Dr. Alexandre de Matos Soeiro – Cardiologist and Intensivist – Incor (HCUSP)
Dr. Paulo Fernando Guimarães Morando Marzocchi Tierno - Intensivist – SPDM (São Paulo)
Approval of CONEP