All studies
Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

MESENCHYMAL STROMAL CELL THERAPY FOR THE TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME - Validation of Mechanistic Pathways and Clinical Efficacy

This research is investigating a new treatment named 'mesenchymal stromal cell therapy' for a severe lung illness known as Acute Respiratory Distress Syndrome, or ARDS. ARDS can make it very difficult to breathe. This study is in its very first stage of testing in humans, meaning it's primarily focused on understanding if the treatment is safe for people to use and how it affects the body. Researchers also want to find out more about the specific ways this therapy might help improve lung function. The aim is to gather important information that could lead to better treatments for ARDS in the future, helping patients to breathe easier and recover better. Anyone over 18, male or female, might be able to take part.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Region Uppsala
Enrolment target
7
Start
25 Oct 2024

What is this study about?

Acute Respiratory Distress Syndrome, often called ARDS, is a very serious lung condition. It happens when the lungs are severely injured, making it difficult for oxygen to get into the blood. This can be caused by various illnesses like pneumonia or severe injuries. When someone has ARDS, their lungs become inflamed and filled with fluid, meaning they can't work properly to help them breathe.

This particular study is looking into a new type of treatment called 'mesenchymal stromal cell therapy'. These cells are like special repair cells in our body. Researchers believe they might help reduce inflammation and repair damaged lung tissue in people with ARDS. This is a very early study, sometimes called a Phase 1 study, which means it's one of the first times this treatment is being given to people.

The main goals of this study are to see if this new treatment is safe for people with ARDS and to understand how it works within the body. By learning more about these 'repair cells' and their effects, doctors hope to develop more effective ways to help people with ARDS recover and improve their breathing.

Key takeaways

  • New study for a serious lung condition called ARDS.
  • Investigating a new cell-based therapy.
  • Early stage (Phase 1) focused on safety and how the treatment works.
  • Aimed at people 18 years and older with ARDS.
  • Could help scientists develop better treatments for ARDS in the future.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women can take part in this research.

Since this is a study for people with Acute Respiratory Distress Syndrome (ARDS), you would need to have this specific lung condition. The doctors running the study will carefully check your medical history and current health to make sure that taking part would be suitable and safe for you.

There might be other specific health requirements or conditions that would mean you couldn't join, but these would be explained by the study team. They need to ensure that everyone in the study is as safe as possible and that the results they get are clear and helpful.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have Acute Respiratory Distress Syndrome (ARDS)?
  3. Are you male or female?
  4. Are you able to attend study visits regularly?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new 'mesenchymal stromal cell therapy'. The study team would carefully explain how this is given. You would need to have several visits to the hospital or clinic to check your health, see how the treatment is affecting you, and monitor your breathing and other body functions. These visits would include things like blood tests, physical examinations, and possibly lung function tests.

The doctors and nurses would keep a close eye on you throughout the study to make sure you are doing well. They would likely ask you to answer questions about how you are feeling and any changes you notice. The total length of your participation would be explained to you in detail, including how long you would receive the treatment and how long the follow-up checks would last after your treatment has finished.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit of joining this study is that the new treatment might help improve your ARDS, although this is not guaranteed as it's an early-stage study. You would also contribute to understanding a new therapy that could help many others in the future. Potential risks might include side effects from the treatment, which would be carefully monitored by the study team. They will explain all known potential side effects to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Sweden

Common questions

What is ARDS?

ARDS (Acute Respiratory Distress Syndrome) is a severe lung condition where the lungs are badly inflamed and fill with fluid, making it very hard to breathe.

What is mesenchymal stromal cell therapy?

It's a new type of treatment using special 'repair' cells from the body that researchers hope can help reduce inflammation and fix damaged lung tissue.

What does Phase 1 mean?

Phase 1 means this is one of the very first times this new treatment is being given to people. The main goal is to check if it's safe and how it works.

Who can take part?

Anyone aged 18 or older, male or female, who has been diagnosed with ARDS and meets other health requirements, could potentially take part.

Will this treatment cure my ARDS?

It's too early to say if this treatment will cure ARDS. This study aims to see if it's safe and if it shows promise for helping patients.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.