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Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

NCT ID: NCT04611256

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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

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Covid19

Keywords

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COVID-19 Adjuvant therapy mesenchymal stem cells Mexico

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MSC transfusion

Group Type EXPERIMENTAL

MSC

Intervention Type BIOLOGICAL

Two intravenous infusion of 1\*10E6 adipose tissue derived-MSCs /kg body weight reach

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DRUG

Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.

Interventions

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MSC

Two intravenous infusion of 1\*10E6 adipose tissue derived-MSCs /kg body weight reach

Intervention Type BIOLOGICAL

Control

Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Terapia Celular: ITC

UNKNOWN

Sponsor Role collaborator

Hospital Reg. Lic. Adolfo Lopez Mateos

OTHER_GOV

Sponsor Role lead

Responsible Party

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M. Eunice Rodríguez Arellano

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Regional Lic Adolfo Lopez Mateos

Mexico City, Ciudad de Mexico CDMX (Mexico City), Mexico

Site Status RECRUITING

Countries

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Mexico

Facility Contacts

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Martha E. Rodríguez Arellano, MD

Role: primary

Other Identifiers

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060I.2020

Identifier Type: -

Identifier Source: org_study_id