Mesenchymal Stromal Cells for the Treatment of Patients With COVID-19.

NCT ID: NCT05433298

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-03-31

Brief Summary

The purpose of this study is evaluate the feasibility, safety and potential efficacy of an advanced cell therapy product for the treatment of patients with SARS-CoV-2 pneumonia.

Detailed Description

Forty patients with COVID-19 will receive an intravenous infusion of one dose of 1.000.000 umbilical cord mesenchymal cells per kilo of the patient. Twenty patients will receive a placebo (Ringer's lactate solution, albumin and heparin). Conventional treatment will be performed together with the infusion of cells, during the study period. The evaluation times will be at pre-infusion, 6 and 24 hours, days 5 and 28, 3 and 6 months. The patient exams performed: serology, biochemistry, blood count and blood gas analysis, metabolomics/proteomics, antibody evaluation, electrocardiogram, CT-scan and X-ray, cytokines, viral load, cytometry, and clinical evaluation. The patients will be evaluated all the time, during hospitalization period, to assess adverse events.

Conditions

COVID-19 Pneumonia; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment

Patient: Intravenous infusion of single-dose of Mesenchymal stem cells (MSCs)

Group Type: EXPERIMENTAL

Mesenchymal stem cell

Intervention Type: BIOLOGICAL

Administration of advanced cell product

Placebo

Intravenous infusion of single-dose of Ringer's lactate, albumin and heparin solution

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Ringer's lactate, albumin and heparin solution

Interventions

Mesenchymal stem cell

Administration of advanced cell product

Intervention Type: BIOLOGICAL

Placebo

Ringer's lactate, albumin and heparin solution

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Both sexes;
• aged 18 to 79 years old;
• hospitalized patients;
• radiological diagnosis of viral pneumonia;
• virological diagnosis of SARS-CoV-2 infection;
• with noninvasive ventilatory support;
• C-reactive protein and ferritin above the reference value considered normal;
• assent confirmed to participate in the study.

Exclusion Criteria

• Contraindications for use of corticosteroids;
• immunosuppressive, cytotoxic and antiviral treatment, experimental medications and chronic corticosteroid use;
• morbid obesity (BMI> 35);
• multiple organ dysfunction syndrome;
• pre-malignant neoplastic conditions with life expectancy lower than 1 year old;
• pre-existing chronic illnesses like chronic dialysis kidney disease, chronic liver disease, congestive heart failure Class IV; pulmonary hypertension (WHO Class III/IV);
• pre-existing or current thromboembolic pathology;
• transplanted patients;
• pre-existing severe allergic reaction;
• history of HIV and tuberculosis;
• enrollment in another clinical trial;
• pregnancy or breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Paulo Brofman

OTHER

Sponsor Role: lead

Responsible Party

Paulo Brofman

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paulo R Brofman, phD

Role: PRINCIPAL_INVESTIGATOR

Pontifícia Universidade Católica do Paraná

Locations

Paulo Roberto Slud Brofman

Curitiba, Paraná, Brazil

Countries

Brazil

References

Rebelatto CLK, Senegaglia AC, Franck CL, Daga DR, Shigunov P, Stimamiglio MA, Marsaro DB, Schaidt B, Micosky A, de Azambuja AP, Leitao CA, Petterle RR, Jamur VR, Vaz IM, Mallmann AP, Carraro Junior H, Ditzel E, Brofman PRS, Correa A. Safety and long-term improvement of mesenchymal stromal cell infusion in critically COVID-19 patients: a randomized clinical trial. Stem Cell Res Ther. 2022 Mar 21;13(1):122. doi: 10.1186/s13287-022-02796-1.

Reference Type: BACKGROUND

PMID: 35313959 (View on PubMed)

Senegaglia AC, Rebelatto CLK, Franck CL, Lima JS, Boldrini-Leite LM, Daga DR, Leitao CA, Shigunov P, de Azambuja AP, Bana E, Marsaro DB, Schaidt B, Micosky A, Jamur VR, Schluga Y, Vaz IM, Ribeiro LL, Correa A, Brofman EPRS. Combined Use of Tocilizumab and Mesenchymal Stromal Cells in the Treatment of Severe Covid-19: Case Report. Cell Transplant. 2021 Jan-Dec;30:9636897211021008. doi: 10.1177/09636897211021008.

Reference Type: BACKGROUND

PMID: 34074163 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/35313959/

UC-MSCs infusion is safe and can play an important role as an adjunctive therapy, both in the early stages, preventing severe complications and in the chronic phase with postacute sequelae reduction in critically ill COVID-19 patients.

https://pubmed.ncbi.nlm.nih.gov/34074163/

The combination of tocilizumab and UC-MSC proved to be safe, with no adverse effects, and the results of this case report prove to be a promising alternative in the treatment of patients with severe acute respiratory syndrome due to SARS-CoV-2.

Other Identifiers

U1111-1267-1200

Identifier Type: OTHER

Identifier Source: secondary_id

31935420.7.1001.0020

Identifier Type: OTHER

Identifier Source: secondary_id

MSC SARS-CoV-2

Identifier Type: -

Identifier Source: org_study_id