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

NCT04896853 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: PRO TRANS 19+2020-002078-29
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Influenza A; Metapneumovirus Pneumonia; Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (9)

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

  7 days

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

  15 days

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

  30 days

• Time to clinical improvement after ProTrans® - MSC infusion

  30 days

• Effect of of ProTrans® -MSC on lung damage

  Up to 60 days

Study Arms (1)

Treatment

EXPERIMENTAL

Wharton'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.

Biological: ProTrans®

Interventions

ProTrans® BIOLOGICAL

Allogeneic Wharton's jelly (WJ) Mesenchymal Stromal Cells

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years old
• 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
• 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

You may not qualify if:

• Inability to provide informed consent
• 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
• 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

Sponsors & Collaborators

• NextCell Pharma Ab: lead
• Karolinska Trial Alliance: collaborator

Study Sites (1)

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

Örebro, 701 85, Sweden

Location

Study Officials

• Mathias Svahn, PhD

  NextCell Pharma

  STUDY CHAIR

• Josefine Sundh, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is an open, dose escalating Phase IB Clinical Trial

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: May 18, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)