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

NCT05433298 | Withdrawn Phase 1 DMC

• 3 other identifiers: MSC SARS-CoV-2U1111-1267-120031935420.7.1001.0020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia; COVID-19

Outcome Measures

Primary Outcomes (1)

• Safety of intravenously infused UCT-MSC suspension

  The primary expected outcome is the safety and tolerability of using intravenously infused UTC-MSC suspension in patients with pneumonia caused by SARS-CoV-2. This outcome will be evaluated by recording adverse events that must be reported throughout the study period.

  After first cell infusion until the end of study. The clinical follow-up of patients will be one year after the transplant.

Secondary Outcomes (12)

• Pulmonary function test to evaluate the improvement of respiratory function

  Pre-infusion, on days 5 and 28, 3 and 6 months.

• Radiography to evaluate the improvement of respiratory function

  Pre-infusion, on days 5 and 28, 3 and 6 months.

• 6-minute walk to evaluate the improvement of respiratory function

  Pre-infusion, on days 5 and 28, 3 and 6 months.

• Decrease on days of non-invasive mechanical ventilation

  Six hours after infusion, days 1, 5 and 28, 3 and 6 months.

• Biochemical tests to evaluate the improvement of laboratory parameters

  Pre-infusion, on days 1, 5 and 28, 3 and 6 months.

Study Arms (2)

Treatment

EXPERIMENTAL

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

Biological: Mesenchymal stem cell

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Mesenchymal stem cell BIOLOGICAL

Administration of advanced cell product

Treatment

Placebo OTHER

Ringer's lactate, albumin and heparin solution

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paulo Brofman: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Paulo Roberto Slud Brofman

Curitiba, Paraná, 80215200, Brazil

Location

Related Publications (2)

• 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.

  PMID: 35313959 BACKGROUND

• 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.

  PMID: 34074163 BACKGROUND

Related Links

• 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.
• 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paulo R Brofman, phD

  Pontifícia Universidade Católica do Paraná

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 27, 2022
• Study Start: May 1, 2022
• Primary Completion: November 26, 2022
• Study Completion: March 31, 2023
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)