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Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans® | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®

Treatment of Respiratory Complications Associated With COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus Infection Using Wharton's Jelly-Umbilical Cord Mesenchymal Stromal Cells (ProTrans®): Open Phase IB Clinical Trial

NCT04896853•NextCell Pharma Ab

View on ClinicalTrials.gov

Summary

To investigate the safety and tolerance of a single infusion of ProTrans® in subjects with "severe" respiratory complications associated with pneumonia caused by COVID-19, Influenza A, Metapneumovirus or RSV infection.

Detailed Description

The investigators hypothesize that the systemic delivery of WJ-MSCs exerts an anti-inflammatory action and anti-apoptotic effect in the lung of COVID-19, Influenza A, Metapneumovirus or RSV patients. The nature of these cells to immunomodulate both tissue resident and bloodborne immune cells towards a more anti-inflammatory and tolerogenic profile, results in a reduction of tissue-based inflammation within the lung and triggering of repair responses. This clinically culminates in a beneficial action on patients with "severe" respiratory complications associated with pneumonia.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female, aged ≥18 years old
•Has laboratory-confirmed SARS-CoV-2, Influenza A, Metapneumovirus or RSV infection as determined by reverse-transcription polymerase chain reaction (RT-PCR) in any specimen prior to inclusion.
•Hospitalized patients.
•Patients classified as severe pneumonia, as defined by the need for continuous supplemental oxygen 5 L/min 02 OR high flow oxygen, 35% FiO2 \> 30l/min and cannot saturate \> 96% NOT under "non-invasive" ventilation NOR invasive mechanical ventilation NOR ECMO.
•Women of childbearing potential must agree to use contraception or acceptable birth control for the duration of the study. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1:
•* oral
•* intravaginal
•* transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation 1:
•* oral
•* injectable
+5 more criteria

Exclusion Criteria

•Inability to provide informed consent
•Patients not expected to survive for 24 hours or mechanically ventilated at inclusion or previously during present hospitalization
•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test
•Patients with BMI ≥30
•Patients with known, or previous, malignancy
•Patients with other serious systemic diseases deemed of contra-indication by the physician
•Patient with any of following laboratory results out of the ranges detailed below at screening: Absolute neutrophil count (ANC) ≤ 1.0 x 10e9/L, Platelets (PLT) \< 50 10e9 /L, ASAT or ALAT \> 5N, estimated glomerular filtration rate (eGFR) \< 30 mL/min
•Current documented bacterial infection
•Serological evidence of infection with human immunodeficiency virus, Treponema pallidum, hepatitis B antigen (serology consistent with previous vaccination and a history of vaccination is acceptable) or hepatitis C
•Latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or have travelled in areas with high risk of tuberculosis or mycosis within the last 3 months
+8 more criteria

Locations (1)

Department of Cardiology, Respiratory medicine and Physiology, Örebro University Hospital

Örebro, Sweden

Key Dates

Start Date

May 18, 2021

Primary Completion Date

March 31, 2027

Completion Date

May 31, 2027

Last Updated

May 14, 2025

Enrollment

ESTIMATED participants

Conditions

COVID-19 Acute Respiratory Distress SyndromeInfluenza AMetapneumovirus PneumoniaRespiratory Syncytial Virus (RSV)

Interventions

ProTrans®

BIOLOGICAL

A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

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Influenza A

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®

Inclusion Criteria

Exclusion Criteria

A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

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