MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

D'Or Institute for Research and Education

Status and phase: Unknown; Phase 1

Conditions: Covid19; ARDS, Human

Treatments: Other: Mesenchymal stromal cell-based therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04525378

PCL02/2020

Details and patient eligibility

About

Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of COVID-19 confirmed by RT-PCR;
• Thorax CT image suggestive of viral pneumonia;
• Respiratory failure (SaO2 <93% with O2 at 5L / min)
• Tracheal intubation (first 48 h);

Exclusion criteria

• Pregnancy or breastfeeding;
• Patients with a history of cancer, chemotherapy in the past 2 years;
• Life expectancy less than 6 months or in exclusive palliative care;
• Severe liver failure, with Child-Pugh score> 12;
• High probability of death in the following 48 h;
• Previous renal failure: patients who were already on dialysis or patients with RFG <30ml / min / 1.73 m2;
• Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 4 patient groups

Control

No Intervention group

Description:

Patients will receive standard care.

MSC - low dose (2.5x10ˆ7)

Experimental group

Description:

Patients will receive standard care plus cell therapy.

Treatment:

Other: Mesenchymal stromal cell-based therapy

MSC - intermediate dose (5x10ˆ7)

Experimental group

Description:

Patients will receive standard care plus cell therapy.

Treatment:

Other: Mesenchymal stromal cell-based therapy

MSC - high dose (10x10ˆ7)

Experimental group

Description:

Patients will receive standard care plus cell therapy.

Treatment:

Other: Mesenchymal stromal cell-based therapy