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COVID-19 Acute Respiratory Distress SyndromePhase 1NCT04896853

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

A Phase 1 study testing ProTrans® in people with COVID-19 Acute Respiratory Distress Syndrome and Influenza A, run by NextCell Pharma Ab at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
ProTrans®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteSweden
Study dates
18 May 2021to 31 May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • intravaginal
  • transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation 1:
  • oral
  • injectable
  • implantable 2; intrauterine device (IUD) 2, intrauterine hormone-releasing system (IUS) 2, bilateral tubal occlusion 2, vasectomised partner 2,3, sexual abstinence 4
  • Hormonal contraception may be susceptible to interaction with the Investigational Medicinal Products (IMP), which may reduce the efficacy of the contraception method
  • Contraception methods that in the context of this guidance are considered to have low user dependency.
  • Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success. 4 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
  • Provision of a written informed consent

Who cannot join

  • 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
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  • 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
  • Patients with known allergies to a component of the ProTrans® product
  • Ongoing treatment with Remdesivir
  • Pre-existing chronic respiratory diseases requiring long- term oxygen therapy
  • Pre-existing cirrhosis with basal Child and Pugh of C
  • Patients with history of increased risk for thrombo- embolic and/or co-morbidity for thrombo- embolism
  • Patients with a history of myocardium infarction
  • A history of cardiac dysfunction, as assessed as:
  • Clinical sign of a congestive heart failure refractory; Left ventricular ejection fraction <35% at myocardial scintigraphy or echocardiography; Pulmonary arterial hypertension with systolic pulmonary artery pressure (PAP) at echography > 40 mmHg Chronic atrial fibrillation requiring oral anticoagulant therapy; Uncontrolled ventricular arrhythmia; Pericardial effusion with hemodynamic compromise assessed by echocardiography.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

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

    Örebro, 701 85

Other trials in Sweden

About this study

Official title: 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

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.

Read the 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.

Being tested
ProTrans®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProTrans®Biological

    Allogeneic Wharton's jelly (WJ) Mesenchymal Stromal Cells

Study groups in NCT04896853
Study groupRoleWhat they receive
TreatmentExperimentalWharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®).Study patients 1-3 will receive a single dose of 25 million cells, patients 4-6 will receive 100 million cells and patients 7-9 will receive 200 million cells.
Receives: Biological: ProTrans®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerance of a single infusion of ProTrans®

    Grade 3 or 4 adverse event but not usual in natural course of the disease.

    Measured: 24 months

Secondary outcomes (9)

  1. Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 7

    Effect of ProTrans® -MSC on patient clinical status as assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) 7. Death.

    Measured: 7 days

  2. Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 15

    Effect of ProTrans® -MSC on patient clinical status as assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death.

    Measured: 15 days

  3. Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 30

    Effect of ProTrans® -MSC on patient clinical status as assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death.

    Measured: 30 days

  4. Time to clinical improvement after ProTrans® - MSC infusion

    Time to clinical improvement of one category from admission on the 7-point ordinal scale after ProTrans® - MSC infusion

    Measured: 30 days

  5. Effect of of ProTrans® -MSC on lung damage

    Lung damage examination using imaging techniques (Chest X ray/CT scan /or on doppler ultrasound) when assessed for clinical need up to hospital discharge X ray/CT scan /or on doppler ultrasound) when assessed for clinical need

    Measured: Up to 60 days

  6. Duration of hospitalization and Intensive Care Unit (ICU) stay

    Duration of hospitalization and ICU stay

    Measured: Up to 60 days

  7. Kinetics of COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) viral load after ProTrans® -MSC infusion

    Quantitative PCR for SARS-CoV, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) virus in throat swabs (time frame: before MSC infusion on Day 0 and after MSC infusion on day 30)

    Measured: Up to 30 days

  8. Evolution of biological markers of liver, myocardium and inflammation

    Evaluation of different biomarker after ProTrans® -MSC infusion

    Measured: Up to 24 months

  9. Tolerance of allogeneic Wharton's jelly (WJ) Mesenchymal Stromal Cells (ProTrans®) for severe COVID-19, Influenza A, Metapneumovirus or RSV respiratory conditions

    Investigation of tolerance of Wharton's jelly (WJ) Mesenchymal Stromal Cells (ProTrans®) for treatment of viral respiratory tract infections

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start18 May 2021
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open, dose escalating Phase IB Clinical Trial
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04896853
Sponsor's protocol ID
PRO TRANS 19+
Other IDs
2020-002078-29
Status last verified
May 2025
First submitted
18 May 2021
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ProTrans® in people with COVID-19 Acute Respiratory Distress Syndrome and Influenza A, run by NextCell Pharma Ab at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerance of a single infusion of ProTrans® (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04896853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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