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Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

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ClinicalTrials.gov Identifier: NCT04611256
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Instituto de Terapia Celular: ITC
Information provided by (Responsible Party):
M. Eunice Rodríguez Arellano, 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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: MSC Drug: Control Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Therapy With Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 in Critical Condition
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: MSC transfusion Biological: MSC
Two intravenous infusion of 1*10E6 adipose tissue derived-MSCs /kg body weight reach

Active Comparator: Control Drug: Control
Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.




Primary Outcome Measures :
  1. Change form baseline in Arterial oxygen saturation [ Time Frame: up to 25 days ]
    Pulmonary lesion area will be taken by a chest x-ray or computed axial tomography

  2. Change form baseline in Arterial oxygen saturation [ Time Frame: up to 25 days ]
    Aretrial oxygen saturation will be taken by an oximeter

  3. Days to clinical improvement [ Time Frame: up to 25 days ]
    Number of days of patient discharge


Secondary Outcome Measures :
  1. Change Form Baseline in C reactive protein at 25 days [ Time Frame: up to 25 days ]
    Blood samples will be taken on days 1, 3, 7, 15, 20, 25

  2. Change Form Baseline Immune cells: CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes [ Time Frame: up to 25 days ]
    Blood samples will be taken on days 1, 3, 7, 15, 20, 25

  3. Change Form Baseline in pro-inflammatory cytokines: IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10 [ Time Frame: up to 25 days ]
    Blood samples will be taken on days 1, 3, 7, 15, 20, 25

  4. Change Form Baseline in Immunoglobulins; IgA, IgG, IgM, and IgE. [ Time Frame: up to 25 days ]
    Blood samples will be taken on days 1, 3, 7, 15, 20, 25



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611256


Locations
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Mexico
Hospital Regional Lic Adolfo Lopez Mateos Recruiting
Mexico City, Ciudad De Mexico CDMX (Mexico City), Mexico, 01030
Contact: Martha E. Rodríguez Arellano, MD    +52 5512999131    marthaeunicer@yahoo.com.mx   
Sponsors and Collaborators
Hospital Reg. Lic. Adolfo Lopez Mateos
Instituto de Terapia Celular: ITC
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Responsible Party: M. Eunice Rodríguez Arellano, MD, Hospital Reg. Lic. Adolfo Lopez Mateos
ClinicalTrials.gov Identifier: NCT04611256    
Other Study ID Numbers: 060I.2020
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos:
COVID-19
Adjuvant therapy
mesenchymal stem cells
Mexico
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases