RecruitingRare disease

Study on the Effects of Wharton's Jelly Mesenchymal Stem Cells, Pirfenidone, and Nintedanib for Patients with Fibrotic Interstitial Lung Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for fibrotic interstitial lung diseases, which include conditions like idiopathic pulmonary fibrosis and lung fibrosis that can occur after recovering from COVID-19. The treatment being tested involves the use of allogeneic mesenchymal stem cells derived from Wharton's jelly, which are special cells that may help repair lung tissue. These stem cells are given as an injection. The study also involves other medications, such as Esbriet (pirfenidone) and Ofev (nintedanib), which are taken orally as tablets or capsules.

The purpose of the study is to evaluate the safety and effectiveness of these treatments in managing fibrotic lung diseases. Participants in the study will receive either the stem cell treatment, one of the medications, or a placebo. The study will monitor the number and severity of any side effects, changes in lung function, quality of life, and overall survival over the course of the study.

Throughout the study, participants will undergo regular check-ups to assess their lung function and overall health. The study aims to determine if the new treatment can slow down the progression of lung disease and improve the quality of life for those affected. The trial is expected to continue until March 2025, with ongoing assessments to gather comprehensive data on the treatment's impact.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the study criteria.
Step 3
Treatment with pirfenidone
You will begin treatment with pirfenidone, which is administered orally in the form of Esbriet 267 mg film-coated tablets. The dosage and frequency will be determined by the study team based on your specific needs.
Step 4
Treatment with nintedanib
You will also receive nintedanib, administered orally as Ofev 100 mg soft capsules. The dosage and frequency will be specified by the study team.
Step 5
Stem cell treatment
You will receive an injection of allogeneic mesenchymal stem cells derived from Wharton's jelly. This treatment is part of the study's main objective to evaluate its safety and effectiveness.
Step 6
Monitoring and follow-up
Throughout the study, regular monitoring will be conducted to assess your health and the effects of the treatments. This includes evaluating lung function, quality of life, and any side effects.
Step 7
Completion of the study
At the end of the study, a final assessment will be conducted. This will include a review of your overall health and any changes in your condition.

Who can join the trial?

10 criteria

Patients must be over 18 years of age.
For Group I: Patients must have a diagnosis of idiopathic pulmonary fibrosis (IPF), which is a type of lung disease that causes scarring of the lungs.
For Group I: The diagnosis should be based on a specific type of lung scan or a lung tissue biopsy.
For Group I: Patients must have a lung function test result called FVC (Forced Vital Capacity) greater than 40% of the normal value.
For Group I: Patients must have a lung function test result called DLCO (Diffusing Capacity of the Lung for Carbon Monoxide) greater than 25% of the normal value.
For Group I: Patients must have shown a progression in FVC greater than 10% over the past year.
For Group II: Patients must have a history of severe pneumonia caused by COVID-19.
For Group II: Patients must have a negative test for the COVID-19 virus at least 4 weeks before joining the study.
For Group II: Patients must have a diagnosis of lung scarring after COVID-19.
All patients must sign an Informed Consent Form (ICF), which means they agree to participate in the study after being informed about it.

Who cannot join the trial?

10 criteria

Patients with any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of allergic reactions to similar treatments.
Patients who are unable to follow the study procedures or instructions.
Patients with a history of drug or alcohol abuse.
Patients with unstable or uncontrolled medical conditions.
Patients who have received an organ transplant.
Patients with active infections that require treatment.
Patients with a history of cancer within the last 5 years, except for certain skin cancers.

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Uniwersyteckie Centrum Kliniczne
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Gdansk, Poland

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Investigated drugs

Wharton's Jelly Mesenchymal Stem Cells (WJMSCs) are a type of stem cell therapy being tested in this clinical trial. These cells are derived from a part of the umbilical cord known as Wharton's Jelly. The goal of using these cells is to see if they can help treat lung diseases that cause scarring, such as idiopathic pulmonary fibrosis and lung fibrosis that can occur after COVID-19. The therapy involves using these special cells to potentially repair and reduce damage in the lungs, improving breathing and lung function. The trial is also focused on ensuring that this treatment is safe for patients.

What is already known about the treatment

Wharton's jelly mesenchymal stem cells (WJMSCs) – This medication is administered through an injection, where the stem cells are introduced directly into the body. Currently, it is being studied in clinical trials for its potential use in treating fibrotic interstitial lung diseases, including idiopathic pulmonary fibrosis and pulmonary fibrosis following COVID-19. The main therapeutic indication is to help repair and reduce lung fibrosis, which is a condition where lung tissue becomes damaged and scarred. At the molecular level, these stem cells are believed to work by reducing inflammation and promoting the repair of damaged tissues. They are classified under regenerative medicine due to their ability to potentially regenerate and repair damaged tissues.

Investigated diseases

Fibrotic Interstitial Lung Disease – This disease involves the thickening and scarring of the lung tissue, which can lead to a decrease in lung function. The scarring, known as fibrosis, makes it difficult for the lungs to transport oxygen into the bloodstream. Over time, the lung tissue becomes increasingly stiff, which can cause breathing difficulties. The progression of the disease can vary, with some individuals experiencing a slow decline in lung function, while others may have a more rapid progression. The condition can be triggered by various factors, including environmental exposures, infections, or autoimmune diseases. It is characterized by persistent cough and shortness of breath, which can worsen as the disease advances.