RBR-65trt53
Other
Phase 1
Double-blind, randomized, placebo-controlled study to assessSafety and Effectiveness of Protection Against SARS-Cov-2 Infection: Infusion ofMesenchymal Stem Cells (MSCs) from expanded deciduous tooth pulps,As Allogeneic Therapeutic Strategy.
R-Crio Criogenia S.A.0 sitesDecember 14, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- R-Crio Criogenia S.A.
- Status
- Other
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Man or woman; aged 60 years or over; with laboratory confirmation of the infection (COVID\-19\) by polymerase chain reaction with reverse transcription (RT\-PCR); presence of at least one risk factor (co\-morbidity) beyond age; adequate and healthy hematological values; hemoglobin 100 g / L, neutrophils 1\.0 x 10 (9\) / L, platelets 150 x 10 (9\) / L; adequate livre function; ALT and AST 2\.5 x ULN, bilirubin 1\.5 x ULN;Adequate renal function; calculated creatinine clearance 50 mL / min; written informed consent signed by the candidate.
Exclusion Criteria
- •Patients with severe allergies; serious basic illnesses that affect survival, including blood disorders, cachexia, active bleeding, severe malnutrition; obstructive pulmonary pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis and other known viral pneumonia or bacterial pneumonia; continuous use of immunosuppressive agents or organ transplants in the last 6 months; cancer being treated or even treated (a formal opinion from the responsible doctor is required); low adherence and unable to complete the full study; increased risk of the subject or other conditions that interfere with the clinical trial and the judgment of results such as excessive stress, sensitivity or cognitive impairment.
Outcomes
Primary Outcomes
Not specified
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