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Study on Mesenchymal Stem Cells for Patients with Systemic Sclerosis and Digital Ulcers

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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 Systemic Sclerosis, a condition that affects the skin and internal organs by causing them to harden and tighten. The trial is investigating a treatment using Mesenchymal stem cells, which are special cells that can develop into different types of cells in the body. These cells are being tested to see if they can help with blood vessel growth and healing in digital ulcers, which are painful sores on the fingers or toes that are common in people with Systemic Sclerosis.

The purpose of the study is to determine if this treatment is safe and potentially effective for patients with Systemic Sclerosis who have complications related to blood flow in their extremities. Participants in the study will receive the treatment through an injection into the muscle. The study will monitor the safety of the treatment over a period of 12 weeks, looking for any side effects or adverse reactions. Additionally, the study will assess changes in pain levels, quality of life, hand function, and the number of digital ulcers.

Throughout the study, various assessments will be conducted to evaluate the impact of the treatment on the severity of the disease, including changes in skin condition and symptoms like Raynaud's phenomenon, which causes fingers and toes to feel numb and cold. The study will also look at changes in blood vessel structure using a technique called nailfold capillaroscopy, which involves examining the small blood vessels near the surface of the skin. The trial aims to provide valuable information on whether Mesenchymal stem cells can be a beneficial treatment option for people with Systemic Sclerosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the study, eligibility is confirmed based on criteria such as being over 18 years old, having a diagnosis of systemic sclerosis, and having at least one active digital ulcer that has not improved with previous treatment.
Informed consent is required to participate, ensuring understanding of the trial's purpose and procedures.
Step 2
Treatment administration
The treatment involves receiving an injection of mesenchymal stem cells into the muscle. This is known as intramuscular administration.
The specific dosage and frequency of the injections are determined by the study protocol and will be explained by the medical team.
Step 3
Monitoring and follow-up
After receiving the treatment, monitoring occurs over a period of 12 weeks to assess any potential side effects or improvements.
Regular check-ups are scheduled to evaluate the treatment's safety and effectiveness, including checking for any local reactions at the injection site or other adverse events.
Step 4
Assessment of outcomes
The primary focus is on the safety of the treatment, looking for any signs of toxicity or adverse reactions.
Secondary outcomes include changes in pain levels, quality of life, hand function, and the number of digital ulcers. These are measured using various scales and questionnaires.
Step 5
Completion of the trial
At the end of the 12-week period, a final assessment is conducted to gather data on the treatment's impact.
Participants may be asked to provide feedback on their experience and any changes in their condition.

Who can join the trial?

4 criteria

Must be over 18 years old.
Must have a confirmed diagnosis of Systemic Sclerosis (SSc) based on the criteria set by the American College of Rheumatology in 2013.
Must have at least one active digital ulcer. This is a painful sore larger than 2 mm in diameter, with visible depth and loss of skin layers, that has not improved after 5 days of intravenous treatment with prostacyclines (a type of medication).
Must provide informed consent, meaning you understand the study and agree to participate.

Who cannot join the trial?

5 criteria

Patients who do not have Systemic Sclerosis cannot participate. Systemic Sclerosis is a condition that affects the skin and other organs.
Patients with certain peripheral vascular complications related to Systemic Sclerosis are needed. Peripheral vascular complications involve problems with blood vessels outside of the heart and brain.
Patients who are not within the specified age range cannot participate. The study is open to adults.
Both male and female patients can participate.
Patients who are considered part of a vulnerable population are not eligible. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk of harm.

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Universitair Medisch Centrum Utrecht
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Utrecht, The Netherlands

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Investigated drugs

Mesenchymal Stem Cells (BM-MSC) are a type of cell therapy used in this clinical trial. These cells are taken from the bone marrow of healthy donors and are known for their ability to help repair and regenerate damaged tissues. In this trial, the stem cells are injected into the muscles of patients who have systemic sclerosis, a condition that affects blood vessels and can lead to painful ulcers on the skin. The goal of using these stem cells is to see if they can help improve blood flow and promote healing in these ulcers, making it a potentially effective treatment for patients with this condition.

Human Mesenchymal Stem Cells

What is already known about the treatment

Mesenchymal Stem Cells (MSC) – This medication is administered through intramuscular injection and is currently being studied for its potential use in treating systemic sclerosis, particularly for improving blood flow and healing in digital ulcers. In medical literature, MSCs are being explored for their ability to promote new blood vessel formation, which could help alleviate symptoms in patients with vascular complications. The main therapeutic indication for MSCs in this trial is systemic sclerosis, a condition that affects the skin and internal organs. At the molecular level, MSCs work by releasing factors that encourage the growth of new blood vessels and reduce inflammation. They are classified pharmacologically as a type of cell therapy, which uses living cells to treat or manage diseases.

Investigated diseases

Systemic Sclerosis – Systemic Sclerosis is a chronic connective tissue disease characterized by the hardening and tightening of the skin and connective tissues. It progresses with the overproduction of collagen, leading to fibrosis of the skin and internal organs. The disease often begins with Raynaud's phenomenon, where fingers and toes turn white or blue in response to cold or stress. As it advances, patients may experience skin thickening, joint pain, and digestive issues. In some cases, it can affect the lungs, heart, and kidneys, causing further complications. The progression varies greatly among individuals, with some experiencing mild symptoms and others facing more severe manifestations.