In short
A new clinical trial is investigating the use of CL-AD-MSC-002, a type of stem cell treatment, for patients suffering from dry mouth (xerostomia) due to Sjögren's syndrome. This study aims to determine if injecting these special cells into the salivary glands can improve saliva production and relieve symptoms associated with this autoimmune condition.
At a glance
- Study Drug
- CL-AD-MSC-002 (adipose-derived mesenchymal stem cells)
- Condition
- Sjögren's Syndrome with xerostomia (dry mouth)
- Administration
- Intraglandular injection into submandibular glands
- Primary Objective
- Measure change in unstimulated whole saliva flow rate (UFR) from baseline to 4 months post-treatment
- Key Inclusion Criteria
- Age >18, diagnosed Sjögren's Syndrome, xerostomia, specific UFR range
- Key Exclusion Criteria
- Xerogenic medications, other salivary gland diseases, previous gland surgery or stem cell treatment
- Secondary Objectives
- Stimulated saliva flow, saliva quality, safety, patient-reported outcomes, immune response, gland morphology changes
What is CL-AD-MSC-002?
CL-AD-MSC-002 is an innovative medical treatment currently being studied for its potential to help patients with dry mouth caused by Sjögren's syndrome. It is classified as a cell therapy, which means it uses living cells as a treatment.
This therapy is administered as an injection directly into the submandibular glands, which are major salivary glands located beneath the floor of the mouth. The treatment uses adipose-derived mesenchymal stem cells, which are special cells taken from fat tissue that have the ability to develop into different types of cells and potentially help repair damaged tissues.
Target Condition: Sjögren's Syndrome
Sjögren's syndrome is an autoimmune disorder that primarily affects the glands that produce tears and saliva. One of the main symptoms is xerostomia, or dry mouth, which can significantly impact a person's quality of life. CL-AD-MSC-002 is being studied specifically to address this symptom in patients with Sjögren's syndrome.
How CL-AD-MSC-002 Works
While the exact mechanism is still being studied, CL-AD-MSC-002 is thought to work by: Potentially repairing damaged salivary gland tissue Possibly reducing inflammation in the affected glands Potentially stimulating the production of saliva The goal is to improve the function of the salivary glands and increase saliva production, which could alleviate the discomfort of dry mouth for patients with Sjögren's syndrome.
Clinical Trial Information
A clinical trial called "ASSIX" (Intraglandular treatment with adipose derived mesenchymal stem cells in patients with xerostomia due to Sjögrens syndrome) is currently underway to study the effectiveness of CL-AD-MSC-002. Here are some key points about the trial: It's a controlled study comparing CL-AD-MSC-002 injections to a placebo (a harmless substance with no active ingredients) The main goal is to measure changes in unstimulated whole saliva flow rate (UFR) from the start of the study to 4 months after treatment The study will also look at other factors such as stimulated saliva flow rate, saliva quality, and patient-reported outcomes This trial aims to provide scientific evidence on whether CL-AD-MSC-002 can effectively improve saliva production and relieve dry mouth symptoms in people with Sjögren's syndrome.
Who Can Participate in the Study?
The study has specific criteria for who can participate. Some key eligibility factors include: Diagnosed with Sjögren's syndrome according to specific medical criteria Age 18 or older Experiencing dry mouth symptoms Having a certain range of unstimulated saliva flow rate There are also factors that would exclude someone from participating, such as: Taking certain medications that can cause dry mouth Having other diseases affecting the salivary glands Previous salivary gland surgery or stem cell treatments in the salivary glands Pregnancy or breastfeeding Recent smoking or excessive alcohol consumption These criteria help ensure the safety of participants and the accuracy of the study results.
Expected Benefits and Outcomes
If successful, CL-AD-MSC-002 could potentially offer several benefits: Increased saliva production, both at rest and when stimulated Improved quality of saliva Relief from dry mouth symptoms Better overall oral health Improved quality of life for people with Sjögren's syndrome The study will measure these outcomes using various methods, including saliva flow tests, questionnaires about dry mouth symptoms, and ultrasound imaging of the salivary glands.
Safety Considerations
As with any new medical treatment, safety is a top priority in the study of CL-AD-MSC-002. The clinical trial will closely monitor for any side effects or adverse events. Some specific safety aspects being evaluated include: Any serious adverse events or unexpected reactions Development of antibodies against the donor cells Changes in overall disease activity of Sjögren's syndrome It's important to note that this treatment is still in the research phase, and more studies may be needed to fully understand its long-term safety and effectiveness.