Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST)

The REALIST study is looking into a new way to treat Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious lung condition where fluid fills the lungs, making it hard to breathe. It often affects very sick patients in intensive care and can be life-threatening. Currently, there aren't many specific drug treatments for ARDS. This study is testing if a special type of cell, called mesenchymal stem cells (MSCs), taken from umbilical cord blood, can help. Researchers believe these cells might reduce inflammation and help repair the lungs. The study will first check the safest dose of these cells, then compare them to a dummy treatment (placebo) to see if they improve lung function in patients with ARDS. This research could open doors for new treatments if the cells prove effective.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Belfast Health and Social Care Trust

Enrolment target

129

Start

07 Jan 2019

Estimated completion

01 Oct 2026

Acute Respiratory Distress Syndrome

What is this study about?

The REALIST study is investigating a serious lung condition called Acute Respiratory Distress Syndrome, or ARDS. When someone has ARDS, their lungs fill with fluid, making it very difficult to breathe properly. This often happens to people who are already very unwell and are being cared for in an Intensive Care Unit. ARDS can be caused by various factors, including severe infections like COVID-19, and it can be life-threatening or lead to long-lasting health problems for those who recover.

At the moment, there aren't many specific medicines that can effectively treat ARDS. Doctors mainly focus on supporting the patient's breathing and overall health. However, recent research suggests that a special type of cell, called mesenchymal stem cells (MSCs), might be helpful. These cells are found in various parts of the body, including umbilical cord blood, and have shown promise in reducing inflammation and helping tissues repair themselves. This study aims to see if giving these cells as a treatment can help patients with ARDS.

The REALIST study will involve giving some patients with ARDS these special MSCs, while others will receive a harmless saltwater solution called a placebo. This is to compare the effects and see if the MSCs truly make a difference in improving lung function and the overall health of patients. The first part of the study will be to find the safest dose of these cells to use. If this research shows that MSCs are safe and effective, it could pave the way for completely new treatments for ARDS, helping countless patients recover better and faster.

Key takeaways

This study is testing a new treatment for severe lung condition called ARDS.
The treatment involves special cells from umbilical cord blood (MSCs).
It aims to see if MSCs are safe and can improve lung function compared to a dummy treatment.
Participation includes a single infusion and close medical monitoring.
If successful, this could lead to new treatments for ARDS patients.

Who may be eligible?

To be considered for this study, you would need to have already been diagnosed with ARDS as defined by specific medical criteria, meaning your lungs are failing within a week of a clear problem, you're experiencing severe breathing difficulties, and lung scans show fluid in your lungs not due to heart issues. You would also need to be on a breathing machine (invasive mechanical ventilation) and your ARDS could be due to COVID-19 or other causes.

There are several reasons why someone might not be able to join the study. If your ARDS started more than 72 hours ago, or if you are under 16 years old, you wouldn't be eligible. Pregnant individuals, those with major injuries in the last three days, or anyone with certain serious ongoing illnesses like active cancer or severe chronic liver disease cannot participate.

Additionally, if you have a current order not to attempt resuscitation (a 'Do Not Attempt Resuscitation' order), are receiving special life support outside the body (ECMO), or if doctors believe your treatment will be stopped within 24 hours, you wouldn't be able to join. Consent is also crucial; if you decline to participate, are a prisoner, or cannot adequately understand the study information even with an interpreter, you would not be able to take part.

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.

Have I been diagnosed with ARDS within the last 72 hours?
Am I 16 years old or older?
Am I currently on a breathing machine (ventilator)?
Do I have any serious active conditions like cancer or severe liver disease?
Am I pregnant?
Do I have a 'Do Not Attempt Resuscitation' order in place?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the REALIST study, you would receive either the investigational treatment (human umbilical cord derived mesenchymal stem cells) or a placebo (a harmless saline solution) through a single infusion into your bloodstream. The study team would closely monitor your health and lung function using various tests and examinations. This monitoring would involve regular checks while you are in the intensive care unit and potentially for a period after, to observe how your lungs are recovering and to check for any effects of the treatment. The total duration of your participation would depend on your hospital stay and follow-up schedule, but the main intervention is a single infusion, with subsequent observation.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of receiving a new treatment that might improve your lung function and recovery from ARDS, especially since current drug treatments are limited. However, like all new treatments, there are potential risks, including side effects from the infusion or the cells themselves, though previous smaller studies have shown these types of cells to be generally safe. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Belfast Health and Social Care Trust, Royal Hospitals
Verified postcode
Belfast, United Kingdom

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where fluid builds up, making it very hard to breathe, often affecting people who are critically ill.

What are MSCs?

MSCs are 'mesenchymal stem cells.' These are special cells, in this study taken from umbilical cord blood, that scientists believe might help reduce inflammation and repair damaged tissues like the lungs.

Is this a new treatment?

Yes, using MSCs to treat ARDS is a new and experimental approach. This study is researching its safety and effectiveness.

Will I know if I'm getting the treatment or the placebo?

No, in this type of study (called a 'blinded' study), neither you nor your doctors will know if you're receiving the active cells or the placebo. This helps ensure fair results.

How will the treatment be given?

If you are in the study, the MSCs or a placebo will be given to you as a single infusion (like a drip) into your bloodstream.