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Allogeneic Wharton’s Jelly-Derived Mesenchymal Stem Cells

This article explores the use of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stem Cells in clinical trials for treating fibrotic interstitial lung disease. These stem cells, derived from the umbilical cord’s Wharton’s jelly, are being investigated as a potential treatment for conditions such as idiopathic pulmonary fibrosis and pulmonary fibrosis after COVID-19. The trials aim to evaluate the safety, effectiveness, and potential benefits of this innovative therapy for patients with these challenging respiratory conditions.

Table of Contents

What are Wharton’s Jelly-Derived Mesenchymal Stem Cells (WJMSCs)?

Allogeneic Wharton’s Jelly-Derived Mesenchymal Stem Cells (WJMSCs), also known as CardioCell, are a type of stem cell treatment being studied for various medical conditions[1]. These cells are:

  • Allogeneic: This means the cells come from a donor, not the patient themselves.
  • Derived from Wharton’s Jelly: Wharton’s jelly is a gelatinous substance found in the umbilical cord, rich in stem cells.
  • Mesenchymal Stem Cells (MSCs): These are multipotent cells that can develop into various cell types, potentially helping in tissue repair and reducing inflammation.
This treatment is classified as an Advanced Therapy Medicinal Product (ATMP) and specifically a Somatic Cell Therapy product[1]. This means it’s a cutting-edge treatment using cells or tissues that have been manipulated to change their biological characteristics.

Target Condition: Fibrotic Interstitial Lung Disease

The primary focus of this treatment is fibrotic interstitial lung disease, particularly:

  • Idiopathic Pulmonary Fibrosis (IPF): A condition where lung tissue becomes scarred for unknown reasons, making breathing difficult.
  • Pulmonary Fibrosis after COVID-19: Lung scarring that occurs as a complication of severe COVID-19 infection.
These conditions fall under the broader category of interstitial lung diseases, which affect the tissue and space around the air sacs of the lungs[1].

Clinical Trial Overview

A clinical trial is currently underway to assess the effectiveness and safety of WJMSCs in treating fibrotic interstitial lung diseases[1]. This trial is:

  • A combined Phase I and Phase IIa trial, meaning it’s testing both safety and initial effectiveness.
  • Aimed at evaluating how well patients tolerate the treatment and its potential benefits.
  • Comparing the results to a control or placebo group to determine if the treatment makes a significant difference.

How is the Treatment Administered?

The WJMSCs are prepared as a suspension for injection[1]. This means the stem cells are suspended in a liquid that can be injected into the patient. The exact method of injection (e.g., intravenous, directly into the lungs) is not specified in the available information but would be explained to participants in the trial.

Who is Eligible for the Treatment?

The trial has specific criteria for who can participate[1]:

  • Patients over 18 years old
  • For IPF patients:
    • Diagnosed with usual interstitial pneumonia (UIP) based on chest CT or lung biopsy
    • Forced Vital Capacity (FVC) > 40% of predicted value
    • Diffusing Capacity for Carbon Monoxide (DLCO) > 25% of predicted value
    • FVC decline greater than 10% during the past year
  • For post-COVID-19 fibrosis patients:
    • History of severe COVID-19 pneumonia
    • Negative SARS-COV2 test at least 4 weeks before study inclusion
    • Diagnosed with interstitial lung fibrosis
There are also several exclusion criteria, including active infections, cancer history, and certain liver or kidney conditions.

Expected Benefits and Outcomes

The researchers hope to see several positive outcomes from this treatment[1]:

  1. Slowing disease progression: Specifically, they aim to inhibit the decline in Forced Vital Capacity (FVC), a measure of lung function.
  2. Improved quality of life for patients.
  3. Reduced number of disease exacerbations (sudden worsening of symptoms).
  4. Increased survival rate over the course of a year.
The trial will also study how the stem cells behave in the body (pharmacokinetics) and their effects (pharmacodynamics).

Safety Considerations

As with any new treatment, safety is a primary concern. The trial will closely monitor[1]:

  • The number and severity of adverse events in both the treatment and control groups.
  • Any unexpected reactions or side effects.
Patients considering this treatment should discuss potential risks and benefits thoroughly with their healthcare provider.

Aspect Details
Study Title Assessment of the effect of Wharton’s jelly mesenchymal stem cell preparation (WJMSCs) in the treatment of fibrotic interstitial lung diseases
Trial Category Phase I and phase IIa integrated clinical trial
Medical Condition Fibrotic interstitial lung disease, including idiopathic pulmonary fibrosis and pulmonary fibrosis after COVID-19
Main Objective Evaluation of usage and safety of allogenic Mesenchymal cells of Wharton’s Jelly as a possible treatment method
Primary Endpoints 1. Number and severity of adverse events
2. Inhibition of FVC decline
3. Improvement in quality of life
4. Annual survival
Drug Information Allogeneic Wharton’s Jelly-Derived Mesenchymal Stem Cells, administered as a suspension for injection
Key Inclusion Criteria 1. Patients over 18 years of age
2. Diagnosis of IPF or restrictive fibrosis after COVID-19
3. Specific lung function parameters (FVC, DLCO)
4. Informed consent
Key Exclusion Criteria 1. Current or history of cancer
2. Active infections
3. Significant coexisting diseases
4. Liver or kidney failure
5. Recent use of tobacco products

FAQ

  • What is the main purpose of the clinical trial using Allogeneic Wharton's Jelly-Derived Mesenchymal Stem Cells? The main purpose of the clinical trial is to evaluate the usage and safety of Allogeneic Wharton's Jelly-Derived Mesenchymal Stem Cells as a possible treatment method for fibrotic interstitial lung disease, particularly idiopathic pulmonary fibrosis and pulmonary fibrosis after COVID-19.
  • Who can participate in this clinical trial? The trial includes two groups of patients: those diagnosed with idiopathic pulmonary fibrosis (IPF) and those with restrictive fibrosis after COVID-19. Participants must be over 18 years old and meet specific criteria related to their condition and lung function.
  • What are the primary endpoints of the study? The primary endpoints include assessing the number and severity of adverse events, inhibiting the decline in forced vital capacity (FVC), improving quality of life, and evaluating annual survival rates in the treated group compared to the control/placebo group.
  • How is the stem cell preparation administered to patients? The Allogeneic Wharton's Jelly-Derived Mesenchymal Stem Cells are administered as a suspension for injection. The exact route of administration is not specified in the provided information, but it is likely through intravenous injection.
  • What are some of the exclusion criteria for the trial? Some exclusion criteria include current or history of cancer, active infections, significant coexisting diseases of other organs, liver or kidney failure, use of tobacco products within 12 weeks prior to screening, pregnancy or breastfeeding, and participation in other drug programs or experimental treatments within 4 weeks prior to enrollment.

Ongoing Clinical Trials on Allogeneic Wharton’s Jelly-Derived Mesenchymal Stem Cells

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

Glossary

  • Allogeneic: Cells or tissues that are obtained from a genetically different donor of the same species. In this context, it means the stem cells are not from the patient's own body.
  • Wharton's Jelly: A gelatinous substance found in the umbilical cord that contains stem cells with unique properties, making them valuable for potential medical treatments.
  • Mesenchymal Stem Cells (MSCs): A type of multipotent stem cell that can differentiate into various cell types, including bone, cartilage, muscle, and fat cells. They also have immunomodulatory and anti-inflammatory properties.
  • Fibrotic Interstitial Lung Disease: A group of lung disorders characterized by inflammation and scarring (fibrosis) of the lung tissue, which can lead to breathing difficulties and reduced lung function.
  • Idiopathic Pulmonary Fibrosis (IPF): A specific type of fibrotic lung disease of unknown cause, characterized by progressive scarring of the lung tissue.
  • Forced Vital Capacity (FVC): The total amount of air exhaled during a forced breath, which is an important measure of lung function in patients with respiratory diseases.
  • DLCO: Diffusing capacity of the lung for carbon monoxide, a test that measures how well oxygen passes from the lungs into the blood.
  • Usual Interstitial Pneumonia (UIP): A specific pattern of lung inflammation and scarring seen on imaging or biopsy, often associated with idiopathic pulmonary fibrosis.
  • Exacerbation: A worsening or flare-up of symptoms in a chronic disease, such as sudden increased difficulty breathing in lung diseases.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics: The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-whartons-jelly-mesenchymal-stem-cells-pirfenidone-and-nintedanib-for-patients-with-fibrotic-interstitial-lung-disease/