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Study on the Effectiveness of CL-AD-MSC-002 Injections for Dry Mouth in Patients with Sjögren's Syndrome

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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 a condition known as Sjögren's Syndrome, which often leads to a symptom called xerostomia, or dry mouth. The study is investigating a treatment using a special type of cell therapy called adipose-derived mesenchymal stem cells, referred to by the code name CL-AD-MSC-002. These stem cells are injected into the salivary glands to see if they can help improve the function of these glands in producing saliva.

The purpose of the study is to compare the effects of the stem cell treatment with a placebo, which in this case is a simple sterile saline solution. Participants will receive either the stem cell treatment or the placebo through an injection directly into their salivary glands. The study will monitor changes in saliva production over a period of four months to determine the effectiveness of the treatment.

Participants in the study will undergo a series of injections and follow-up visits to assess their salivary gland function. The main goal is to see if the stem cell treatment can increase the flow of saliva in patients with Sjögren's Syndrome and reduce the discomfort of dry mouth. This research aims to provide new insights into potential treatments for this condition.

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 study
Upon joining the study, you will be informed about the trial's purpose and procedures. You will need to provide your informed consent, which means you agree to participate after understanding the study details.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of Sjögren's Syndrome and checking your saliva flow rate, which should be between 0.05 ml/min and 3.0 ml/min.
Step 3
Treatment administration
You will receive an injection in your submandibular glands. This injection will contain either adipose derived mesenchymal stem cells or a placebo (sterile isotonic saline water 0.9%). The purpose is to assess the effect on your salivary gland function.
Step 4
Follow-up assessments
Over the next four months, your saliva flow rate will be monitored to measure any changes. This will help determine the effectiveness of the treatment.
Step 5
Final evaluation
At the end of the four-month period, a final evaluation will be conducted to assess the overall impact of the treatment on your condition.

Who can join the trial?

5 criteria

Patients diagnosed with Sjögren's Syndrome according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria for primary Sjögren Syndrome.
Age above 18 years.
Presence of xerostomia (dry mouth).
Unstimulated whole saliva flow rate (UFR) of minimum 0.05 ml/min and maximum 3.0 ml/min.
Ability to provide informed consent (agreement to participate after understanding the study).

Who cannot join the trial?

4 criteria

Patients who do not have **Sjögren's Syndrome** cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Rigshospitalet
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Copenhagen, Denmark

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Investigated drugs

Adipose Derived Mesenchymal Stem Cells are a type of therapy that uses special cells taken from fat tissue. These cells have the ability to develop into different types of cells in the body. In this clinical trial, the stem cells are injected into the submandibular glands, which are one of the glands that produce saliva. The goal of this treatment is to help improve the function of these glands in patients who have dry mouth due to Sjögren's syndrome. By potentially increasing saliva production, this therapy aims to relieve the symptoms of dry mouth and improve the quality of life for patients.

Cl-Ad-Msc-002

What is already known about the treatment

Adipose Derived Mesenchymal Stem Cells – This medication is administered through an injection directly into the submandibular glands. It is currently being studied in clinical trials for its potential use in treating xerostomia, a condition characterized by dry mouth, in patients with Sjögren's Syndrome. The main therapeutic indication is to improve salivary gland function by increasing saliva production. At the molecular level, these stem cells are believed to promote tissue repair and regeneration by differentiating into various cell types and releasing growth factors. They are classified as a type of regenerative medicine.

Investigated diseases

Sjögren's Syndrome – Sjögren's Syndrome is an autoimmune disorder characterized by the body's immune system mistakenly attacking its own moisture-producing glands. This leads to symptoms such as dry mouth and dry eyes, as the salivary and tear glands are primarily affected. Over time, the lack of moisture can cause difficulties in swallowing, speaking, and an increased risk of dental decay. The disease may also affect other parts of the body, including joints, skin, and organs, leading to a range of symptoms like joint pain and fatigue. The progression of Sjögren's Syndrome can vary greatly among individuals, with some experiencing mild symptoms and others facing more severe complications. The condition is often associated with other autoimmune disorders, such as rheumatoid arthritis or lupus.