About the study

MSC Fibro is a pilot study evaluating the safety and efficacy of therapy using Wharton’s Jelly mesenchymal stem cells (MSC) in patients with fibrosing interstitial lung diseases.

The project includes patients with idiopathic pulmonary fibrosis (IPF) and individuals who developed pulmonary fibrosis following COVID-19.

The aim of the study is to determine whether cell therapy can stop or at least slow the progression of lung fibrosis and thereby delay disease progression.

What are fibrosing interstitial lung diseases?

Fibrosing interstitial lung diseases are a group of disorders characterised by progressive damage to lung tissue and its replacement with fibrotic tissue.

This process impairs normal gas exchange, leading to increasing shortness of breath, reduced exercise capacity and gradual deterioration of respiratory function.

One of the most severe forms of this group is idiopathic pulmonary fibrosis (IPF), although similar changes may also develop following severe COVID-19 infection.

Why are new treatment options needed?

Available treatment options for pulmonary fibrosis are limited and in many cases can only slow disease progression.

New therapeutic strategies are therefore needed that may influence the fibrotic process itself, improve treatment safety and offer patients better control of their disease.

MSC Fibro was designed to evaluate a novel therapeutic approach based on cell therapy.

Why mesenchymal stem cells?

The study uses allogeneic mesenchymal stem cells derived from Wharton’s jelly isolated from umbilical cord tissue.

MSCs are being intensively investigated because of their immunomodulatory properties and their potential to support tissue repair processes in damaged organs.

The project evaluates whether administration of an MSC preparation is safe and feasible in patients with pulmonary fibrosis and which treatment dose is best tolerated.

Study design

MSC Fibro is a prospective phase I/IIa pilot study.

The primary endpoint is treatment safety, while the secondary endpoint is treatment efficacy.

The study uses a dose-escalation design. The first patients receive a single dose of MSCs. If no serious adverse events occur, subsequent groups receive two and then three doses of the investigational product.

Cells are administered intravenously in a hospital setting at monthly intervals.

What does participation involve?

Participants receive between one and three doses of the MSC preparation or placebo, depending on their study group assignment.

Administrations take place on day 0, day 30 and day 60.

After the final administration, participants undergo clinical and laboratory follow-up for 12 months.

Study population

Adults diagnosed with idiopathic pulmonary fibrosis (IPF) or pulmonary fibrosis following COVID-19 are eligible for participation.

A total of 36 participants are planned for enrolment and will be divided into four study groups:

• 9 patients with IPF receiving standard treatment and MSC therapy;
• 9 patients with post-COVID pulmonary fibrosis receiving MSC therapy;
• 9 patients with IPF receiving standard treatment and placebo;
• 9 patients with post-COVID pulmonary fibrosis receiving placebo.

Patients with IPF continue standard antifibrotic treatment (pirfenidone or nintedanib), while control groups receive placebo according to the study protocol.

Research team

The project is led by Piotr Trzonkowski, MD, PhD, Professor, Head of the Department and Chair of Medical Immunology at the Medical University of Gdańsk.

The principal investigator is Beata Wajda, MD, PhD, a specialist in pulmonology and internal medicine affiliated with the University Clinical Centre in Gdańsk.

The project also involves Ewa Jassem, MD, PhD, Professor, Head of the Department of Pulmonology at the Medical University of Gdańsk.

Organisational information

The project is funded by the Polish state budget through the Medical Research Agency (MRA) under the funding call for research and development activities in non-commercial clinical trials (call number: ABM/2020/1).

Project number: 2020/ABM/01/00110.

Funding amount: PLN 12,514,945.60.

Project duration: 23 March 2021 – 22 March 2025.