NCT04611256

Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

Adjuvant Therapy With Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 in Critical Condition

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital Reg. Lic. Adolfo Lopez Mateos · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.

Detailed description

Within the epidemic context of phase 3 that currently exists in Mexico, implementation of new treatments that have shown to be beneficial for patients in a critical state in other countries is an urgent need. Adipose tissue derived-mesenchymal stem cells for could favor the regulation of patient immune system to reduce the proinflammatory state and promoting the regeneration of damaged tissues. Patients diagnosed COVID-19 and confirmed positive with the virus by PCR, will be treated with two intravenous infusions MSCs on the day 1 (D1) and the day 3 (D3) of the treatment consisting of 1X106/kg each. We will assess the pulmonary lesion area by chest x-ray or computed axial tomography at baseline and days 2, 3, 5, 10, 15, 20, and 25. Days to clinical improvement (to be evaluated on days 2, 3, 5, 10, 15, 20, 25), considering temperature and other vital signs measurement, arterial oxygen saturation, blood chemistry (including liver function tests), creatine phosphokinase, C reactive protein, immune cells (CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes), pro-inflammatory cytokines (IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10), immunoglobulins (IgA, IgG, IgM, and IgE), HLA profile expression, and weaning from mechanical ventilation.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	MSC	Two intravenous infusion of 1\*10E6 adipose tissue derived-MSCs /kg body weight reach
DRUG	Control	Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-11-30
• Completion: 2020-12-30
• First posted: 2020-11-02
• Last updated: 2020-11-12

Locations

1 site across 1 country: Mexico