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Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

MSC

Control

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Adjuvant therapy, mesenchymal stem cells, Mexico

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Regional Lic Adolfo Lopez MateosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MSC transfusion

Control

Arm Description

Outcomes

Primary Outcome Measures

Change form baseline in Arterial oxygen saturation

Pulmonary lesion area will be taken by a chest x-ray or computed axial tomography

Change form baseline in Arterial oxygen saturation

Aretrial oxygen saturation will be taken by an oximeter

Days to clinical improvement

Number of days of patient discharge

Secondary Outcome Measures

Change Form Baseline in C reactive protein at 25 days

Blood samples will be taken on days 1, 3, 7, 15, 20, 25

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

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

Change Form Baseline in Immunoglobulins; IgA, IgG, IgM, and IgE.

Blood samples will be taken on days 1, 3, 7, 15, 20, 25

Full Information

NCT ID

NCT04611256

First Posted

October 29, 2020

Last Updated

November 9, 2020

Sponsor

Hospital Reg. Lic. Adolfo Lopez Mateos

Collaborators

Instituto de Terapia Celular: ITC

1. Study Identification

Unique Protocol Identification Number

NCT04611256

Brief Title

Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Reg. Lic. Adolfo Lopez Mateos

Collaborators

Instituto de Terapia Celular: ITC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

COVID-19, Adjuvant therapy, mesenchymal stem cells, Mexico

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSC transfusion

Arm Type

Experimental

Arm Title

Control

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

MSC

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Control

Intervention Description

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

Primary Outcome Measure Information:

Title

Change form baseline in Arterial oxygen saturation

Description

Pulmonary lesion area will be taken by a chest x-ray or computed axial tomography

Time Frame

up to 25 days

Title

Change form baseline in Arterial oxygen saturation

Description

Aretrial oxygen saturation will be taken by an oximeter

Time Frame

up to 25 days

Title

Days to clinical improvement

Description

Number of days of patient discharge

Time Frame

up to 25 days

Secondary Outcome Measure Information:

Title

Change Form Baseline in C reactive protein at 25 days

Description

Blood samples will be taken on days 1, 3, 7, 15, 20, 25

Time Frame

up to 25 days

Title

Change Form Baseline Immune cells: CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes

Description

Blood samples will be taken on days 1, 3, 7, 15, 20, 25

Time Frame

up to 25 days

Title

Change Form Baseline in pro-inflammatory cytokines: IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10

Description

Blood samples will be taken on days 1, 3, 7, 15, 20, 25

Time Frame

up to 25 days

Title

Change Form Baseline in Immunoglobulins; IgA, IgG, IgM, and IgE.

Description

Blood samples will be taken on days 1, 3, 7, 15, 20, 25

Time Frame

up to 25 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Hospital Regional Lic Adolfo Lopez Mateos

City

Mexico City

State/Province

Ciudad De Mexico CDMX (Mexico City)

ZIP/Postal Code

01030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martha E. Rodríguez Arellano, MD

Phone

+52 5512999131

marthaeunicer@yahoo.com.mx

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

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