Single center, decentralized, parallel group, open, non-randomized, long-term safety follow-up, and exploratory study of long-term effects on inflammatory, immunological, and aging related biomarkers in study participants treated with MSCs.
This study is investigating a new treatment called StromaForte MSCs. MSCs are a type of cell treatment, and this research aims to understand their long-term safety and how they affect the body. Researchers will be carefully monitoring for any side effects, including serious ones, and looking at how the treatment might influence inflammation, the immune system, and ageing processes over an extended period. It involves adults aged 18 and over, of any sex. While the specific conditions treated aren't mentioned, this study is a crucial step in ensuring that if this treatment is widely used in the future, we have a clear picture of its long-term impact on health and well-being.
At a glance
What is this study about?
This research study is looking into a new treatment called StromaForte MSCs. MSCs are a type of cell that doctors hope could help with various health problems. Before any new treatment can be widely used, it's very important to understand if it's safe over a long period. That's exactly what this study aims to do.
The main goal is to carefully check for any side effects, both mild and serious, that people might experience after receiving the StromaForte MSC treatment. This includes looking at blood tests to see if there are any unusual changes in a person's body after treatment. The study also wants to explore how this treatment might affect important body processes like inflammation (which is your body's response to injury or infection), your immune system (which fights off illness), and even things related to ageing.
By gathering this detailed information, researchers can gain a much better understanding of the long-term impact of StromaForte MSCs on overall health. This helps ensure that any potential future use of this treatment is as safe and effective as possible for patients.
Key takeaways
- This study is testing the long-term safety of a cell treatment called StromaForte MSCs.
- Researchers will look for side effects and monitor blood test changes over time.
- It aims to understand effects on inflammation, immune system, and ageing.
- Adults aged 18 and older, of any sex, can participate.
- Participation involves receiving the treatment, regular check-ups, and blood tests.
- You can withdraw from the study at any time.
Who may be eligible?
To take part in this study, you need to be an adult, which means you must be 18 years old or older. There is no upper age limit, so older adults can also participate.
Both men and women are welcome to join this research. The study is open to people of all sexes. As for specific health conditions, the study details don't mention what conditions are being treated, so this will be discussed with you by the study team.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you comfortable committing to long-term follow-up appointments and tests?
- Are you aware that both men and women can participate?
- Are you willing to share your health information for research purposes?
What does participation involve?
If you decide to take part, you would receive the StromaForte MSC treatment as an infusion. After this, the main focus will be on carefully monitoring your health over a long period. This will involve regular visits to the study centre, where the research team will check for any side effects you might experience. They will also take blood samples for laboratory tests to look for any changes in your body, particularly those related to inflammation, your immune system, and ageing.
You would also be asked to complete questionnaires, like the EQ-5D-5L, which helps understand your general health and how the treatment might affect your quality of life. The exact number of visits, tests, and the total duration of your participation aren't specified here but would be fully explained by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What are MSCs?
MSCs are a type of cell that scientists are studying for their potential to help with various health conditions, but more research is needed to understand their full effects.
What does 'long-term safety' mean?
It means the study will carefully watch for any side effects or health changes that might happen over an extended period, not just immediately after treatment.
Will this study cure my condition?
The main goal of this particular study is to check the safety of the treatment and understand its long-term effects on the body, rather than directly proving a cure for specific conditions.
Do I have to pay to join the study?
No, you do not have to pay to participate in a clinical trial. All study-related treatments and assessments are usually provided free of charge.
What if I experience side effects?
The research team will closely monitor you for any side effects. If you experience any, they will provide appropriate medical care and guidance.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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