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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Treatment of Respiratory Complications Associated with COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) Infection Using Wharton’s Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): open Phase IB Clinical Trial

This is an early-stage medical study, called a Phase 1B clinical trial, looking into a new way to treat severe breathing difficulties. These problems can be caused by common viruses like COVID-19, the flu (Influenza A), metapneumovirus, and RSV (Respiratory Syncytial Virus). The treatment uses special cells, called mesenchymal stromal cells, which come from Wharton's Jelly found in umbilical cords. These cells, known as ProTrans®, are being tested to see if they are safe and to understand how they work in people. Anyone aged 18 or older can potentially take part if they have one of these severe viral infections and related breathing problems. This trial aims to find out if this new therapy could be a future option for very sick patients.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
NextCell Pharma AB
Enrolment target
9
Start
28 Nov 2024

What is this study about?

This clinical trial is designed to investigate a new potential treatment for people who are experiencing severe breathing problems due to various common viral infections. These infections include well-known ones like COVID-19 and the flu (Influenza A), as well as others such as metapneumovirus and Respiratory Syncytial Virus (RSV), which can all lead to serious respiratory illness.

The new treatment being tested uses special cells called mesenchymal stromal cells, which are found in a part of the umbilical cord known as Wharton's Jelly. These cells are thought to have properties that could help reduce inflammation and repair damaged tissues, which is why scientists are interested in using them to help combat the effects of severe viral infections on the lungs. The specific product being studied is called ProTrans®.

This is an early-stage study, known as a Phase 1B trial. This means the main goal is to find out if the treatment is safe for people and to understand how it affects the body, rather than to prove it can cure a disease. If these initial studies show promising results, further research would be done to see how effective it is in larger groups of people. This research is important because it could lead to new ways to help patients with life-threatening breathing problems caused by these viruses.

Key takeaways

  • Tests new cell therapy for severe breathing problems from viruses.
  • Uses special cells from umbilical cords (ProTrans®).
  • Early stage (Phase 1B) focusing on safety, not yet cure.
  • For adults (18+) with COVID-19, flu, RSV, or metapneumovirus.
  • Could lead to new treatments for serious viral respiratory illness.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. Both men and women are eligible to participate.

The study is specifically for people who are unwell due to a severe viral infection affecting their breathing. The viruses they are focusing on include COVID-19, Influenza A (the flu), metapneumovirus, or Respiratory Syncytial Virus (RSV).

Beyond these general points, doctors and nurses involved in the study will have a more detailed list of criteria to decide if this study is right for you. They will check your medical history, current health, and specific condition to make sure it's safe for you to take part and that the study is a good fit.

Quick self-check
  • Am I at least 18 years old?
  • Do I have severe breathing problems due to a viral infection?
  • Has a doctor told me I have COVID-19, flu, RSV, or metapneumovirus?
  • Am I willing to consider an experimental treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Details about participation, such as how many visits you would need, what tests would be involved, what medication you would receive, and the total duration of the study, are not provided in this brief summary. Typically, clinical trials involve regular check-ups, blood tests, and other assessments to monitor your health and the effects of the treatment. You would likely receive the study treatment and then be observed closely for a period to see how you respond. There would also be follow-up appointments to track your recovery and any long-term effects. This is an early-stage trial, so participation would likely involve close monitoring.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. A potential benefit of this study could be receiving a new, experimental treatment that might help with severe breathing problems caused by viral infections, especially if current treatments aren't fully effective for you. However, this is an early-stage trial, so it's not known if the treatment will be effective, and its primary purpose is to assess safety. Potential risks include side effects from the study treatment, which are not yet fully understood, or other unforeseen complications. You would be closely monitored for any adverse reactions. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

  • Sweden

Common questions

What kind of viruses is this study looking at?

This study is focused on severe breathing problems caused by viruses like COVID-19, the flu (Influenza A), metapneumovirus, and RSV (Respiratory Syncytial Virus).

What is the new treatment they are testing?

The treatment uses special cells called mesenchymal stromal cells, taken from umbilical cords (specifically Wharton's Jelly), known as ProTrans®.

What does 'Phase 1B Clinical Trial' mean?

It's an early stage of testing. The main goal is to see if the treatment is safe for people and how it works in the body, rather than how effective it is yet.

Who can take part in this study?

People aged 18 and older, both men and women, who have serious breathing issues because of one of the listed viral infections.

Will this treatment cure me?

It's too early to say if this treatment will cure; this trial mainly checks for safety and how the body reacts to the new treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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