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 Netherlands