Clinical study to assess safety and efficacy related to the use of donor stem cells in the treatment of COVID-19.

Phase 1

• Conditions: COVID-19OBESITYDIABETESKIDNEY DISEASECANCERHEART DISEASESSENILITY; CiD-10 B-34.2

• Registration Number: RBR-65trt53
• Lead Sponsor: R-Crio Criogenia S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: Not specified
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified