Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

Phase 1

• Conditions: Covid19
• Interventions: Biological: MSC; Drug: Control

• Registration Number: NCT04611256
• Lead Sponsor: Hospital Reg. Lic. Adolfo Lopez Mateos

Brief 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.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Status Verified: 2020-11
• Study First Posted: 2020-11-02
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-12
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Aged between 18 and 65.
• RT-PCR positive for SARS-CoV-2 (Berlin protocol).
• Moderate to severe acute respiratory insufficiency (100 mmHg <PaO2/FiO2 ≤ 200 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSC transfusion	MSC	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Change form baseline in Arterial oxygen saturation	up to 25 days	Aretrial oxygen saturation will be taken by an oximeter
Days to clinical improvement	up to 25 days	Number of days of patient discharge

Secondary Outcome Measures

Name	Time	Method
Change Form Baseline Immune cells: CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes	up to 25 days	Blood samples will be taken on days 1, 3, 7, 15, 20, 25
Change Form Baseline in C reactive protein at 25 days	up to 25 days	Blood samples will be taken on days 1, 3, 7, 15, 20, 25
Change Form Baseline in pro-inflammatory cytokines: IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10	up to 25 days	Blood samples will be taken on days 1, 3, 7, 15, 20, 25
Change Form Baseline in Immunoglobulins; IgA, IgG, IgM, and IgE.	up to 25 days	Blood samples will be taken on days 1, 3, 7, 15, 20, 25

Trial Locations

Locations (1)

Hospital Regional Lic Adolfo Lopez Mateos; 🇲🇽 Mexico City, Ciudad De Mexico CDMX (Mexico City), Mexico