Use of Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Caused by COVID-19

NCT04456361 | Unknown Early Phase 1

• 1 other identifier: MSC-ARDS-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days post-treatment.

Conditions

ARDS, Human; Covid-19

Outcome Measures

Primary Outcomes (1)

• Oxygen saturation

  Number of patients with changes in percentage of resting Oxygen saturation (%O2)

  Baseline, and at days 2, 4 and 14 post-treatment

Secondary Outcomes (7)

• Oxygen pressure in inspiration

  Baseline, and at days 2, 4 and 14 post-treatment

• ground-glass opacity

  Baseline, and at day 14 post-treatment

• Pneumonia infiltration

  Baseline, and at day 14 post-treatment

• Lactate dehydrogenase

  Baseline, and at days 4 and 14 post-treatment

• C-reactive protein

  Baseline, and at days 4 and 14 post-treatment

Study Arms (1)

COVID-19 patients

EXPERIMENTAL

Treatment consistsof Mesenchymal Stem Cells administered as a one-time, single-dose therapy via IV infusion at a dose of 1 X 10 8 cells.

Biological: Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords

Interventions

Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords BIOLOGICAL

Mesenchymal Stem Cells as a single-dose therapy via IV infusion at a dose of 1 X 10 8 cells.

Also known as: UCMSC

COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to provide informed consent or a legally authorized representative.
• Diagnosis of Acute Respiratory Distress Syndrome according to the Berlin Definition following the failing of prior standard therapy, and other available therapies.
• Mild: 200 mm Hg \< PaO2/FIO2 ≤ 300 mm Hg with PEEP or CPAP ≥ 5 cm H2Oc Moderate: 100 mm Hg \< PaO2/FIO2 ≤ 200 mm Hg with PEEP ≥ 5 cm H2O Severe: PaO2/FIO2 ≤ 100 mm Hg with PEEP ≥ 5 cm H2O
• Diagnostic test positive for SARS-CoV-2
• Age ≥ 18 years
• Any man with a partner of child-bearing potential agrees to use adequate contraception which will include two of the following: hormonal or barrier method of birth control, or abstinence prior to study entry, for the duration of study participation, and for 30 days following completion of therapy.

You may not qualify if:

• Current or anticipated use of other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MSC infusion plus any patently atopic patients who have a history of having experienced an episode of allergic anaphylaxis.
• Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease).
• Known diagnosis of human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• Instituto de Medicina Regenerativa: lead

Study Sites (1)

Instituto de Medicina Regenerativa

Tijuana, Estado de Baja California, 22100, Mexico

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Jesus Perez

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

• Juan Parcero

  Instituto de Medicina Regenerativa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 2, 2020
• Study Start: April 16, 2020
• Primary Completion: February 15, 2025
• Study Completion: November 15, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-01

Locations

ME (1)