Overview

Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

Status:
Recruiting
Trial end date:
2020-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Reg. Lic. Adolfo Lopez Mateos
Collaborator:
Instituto de Terapia Celular: ITC
Criteria
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
t tomography.

- Being under standard therapy for COVID-19.

- Informed consent signed by the patient or a legally acceptable representative (in the
case of the legal representative, informed consent could be obtained by a phone call
or email with the subsequent written confirmation).

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
continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis.

- 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
after the end of the study period.

- Participation in another clinical trial with an experimental drug during the last 30
days.

- Pathologies that in medical judgment constitute a contraindication to participate in
the study.