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.
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.
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.
Inclusion Criteria:
- Aged between 18 and 65.
- RT-PCR positive for SARS-CoV-2 (Berlin protocol).
- Moderate to severe acute respiratory insufficiency (100 mmHg - Confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial - Being under standard therapy for COVID-19. - Informed consent signed by the patient or a legally acceptable representative (in the Exclusion Criteria: - Reserved prognosis (survival expected by the physician of fewer than three days). - Being under immunosuppressive drug treatment. - Severe kidney failure (estimated glomerular filtration rate < 30 ml/min) or under - Immunosuppressed patients (except when the cause is corticosteroid treatment). - Pregnant or lactating women. - Patients who plan to become pregnant during the study period or within six months - Participation in another clinical trial with an experimental drug during the last 30 - Pathologies that in medical judgment constitute a contraindication to participate in
t tomography.
case of the legal representative, informed consent could be obtained by a phone call
or email with the subsequent written confirmation).
continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis.
after the end of the study period.
days.
the study.
Hospital Regional Lic Adolfo Lopez Mateos
Mexico City, Ciudad De Mexico CDMX (Mexico City), Mexico
Investigator: Martha E. Rodríguez Arellano, MD
Contact: +52 5512999131
marthaeunicer@yahoo.com.mx