Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Biological: MSC; Drug: Control

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Ciudad De Mexico CDMX (Mexico City)
    • Mexico City, Ciudad De Mexico CDMX (Mexico City), Mexico, 01030
      • Recruiting
      • Hospital Regional Lic Adolfo Lopez Mateos
      • Contact: Martha E. Rodríguez Arellano, MD; Phone Number: +52 5512999131; Email: marthaeunicer@yahoo.com.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Drug: Control; Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.
Experimental: MSC transfusion	Biological: MSC; Two intravenous infusion of 1*10E6 adipose tissue derived-MSCs /kg body weight reach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change form baseline in Arterial oxygen saturation	Pulmonary lesion area will be taken by a chest x-ray or computed axial tomography	up to 25 days
Change form baseline in Arterial oxygen saturation	Aretrial oxygen saturation will be taken by an oximeter	up to 25 days
Days to clinical improvement	Number of days of patient discharge	up to 25 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Reg. Lic. Adolfo Lopez Mateos
• Collaborators: Instituto de Terapia Celular: ITC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Mexico; mesenchymal stem cells; Adjuvant therapy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 060I.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No