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

Double-blind, randomized, placebo-controlled study to assess Safety and Effectiveness of Protection Against SARS-Cov-2 Infection: Infusion of Mesenchymal Stem Cells (MSCs) from expanded deciduous tooth pulps, As Allogeneic Therapeutic Strategy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-65trt53

Enrollment

Unknown

Registered

2020-12-14

Start date

2021-04-30

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 OBESITY DIABETES KIDNEY DISEASE CANCER HEART DISEASES SENILITY

Interventions

1371 / 5000 Resultados de tradução Experimental Group: Treatment group with allogeneic mesenchymal stem cells (MSCs): The Experimental Group will consist of 24 participants who will receive treatment

DeS: E02.095.147 Terapia Baseada em Transplante de Células e Tecidos

Eligibility

Age

60 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: Determined by the difference in the evolution of clinicas and laboratory conditions between the experimental group and the control group (Placebo) in the treatment of volutear patients for the present clinicas study. The paramentes will be assessed through the following assessments: Titration of IgM and IgG anti-SARS-CoV-2 in patients with confirmed COVID-19 1 month after therapy with infusion with mesenchymal stem cells or placebo associated with convencional therapy; Titration of nonspecific antibodies, lymphocytes and other components of the innate immune system (natural killers, auxiliaries, suppressants, interleukin-6) at the end of the follow-up period (1 month). Computed tomography examinations of the lung should be performed at the beginning of the work, shortly after the diagnosis has been confirmed and at the end of the monitoring period (1 month)	—

Measure

Time frame

Expected outcome 1: Determined by the difference in the evolution of clinicas and laboratory conditions between the experimental group and the control group (Placebo) in the treatment of volutear patients for the present clinicas study. The paramentes will be assessed through the following assessments: Titration of IgM and IgG anti-SARS-CoV-2 in patients with confirmed COVID-19 1 month after therapy with infusion with mesenchymal stem cells or placebo associated with convencional therapy; Titration of nonspecific antibodies, lymphocytes and other components of the innate immune system (natural killers, auxiliaries, suppressants, interleukin-6) at the end of the follow-up period (1 month). Computed tomography examinations of the lung should be performed at the beginning of the work, shortly after the diagnosis has been confirmed and at the end of the monitoring period (1 month)

—

Secondary

Measure	Time frame
Expected Outcome: Decrease in hospital stay for those patients undergoing experimental stem cell therapy: Number of hospitalizations for COVID-19 in the treated group compared to the control group (Placebo) 1 month after therapy.	—

Countries

Brazil

Contacts

Public ContactJose Ricardo Muniz Ferreira

R-Crio Criogenia S.A.

josericardo@r-crio.com+55 19 99156 0438

Outcome results

None listed

Source: REBEC (via WHO ICTRP)