NCT04611256

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

October 29, 2020

Last Update Submit

November 9, 2020

Conditions

Covid19

Keywords

COVID-19Adjuvant therapymesenchymal stem cellsMexico

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Change Form Baseline in C reactive protein at 25 days

    up to 25 days

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

    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

    up to 25 days

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

    up to 25 days

Study Arms (2)

MSC transfusion

EXPERIMENTAL
Biological: MSC

Control

ACTIVE COMPARATOR
Drug: Control

Interventions

MSCBIOLOGICAL

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

MSC transfusion
ControlDRUG

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

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Regional Lic Adolfo Lopez Mateos

Mexico City, Ciudad de Mexico CDMX (Mexico City), 01030, Mexico

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 2, 2020

Study Start

August 1, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)