Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas with stem cells. The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of difficult perianal Crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy. This brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed. Only one of the two patients receives therapy; the other serves as the backup patient. By doing this, another "back-up" patient who might receive no care at all is avoided. An developing alternate approach to allogeneic ADSC injection for the treatment of complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat grafts have been the subject of in-depth research. They are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities. We would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of CD.
NCT05974280 — Crohn Disease
Status: Not yet recruiting
http://inclinicaltrials.com/crohn-disease/NCT05974280/
Empirical Dietary Inflammatory Pattern (EDIP) Based Dietary Suggestion on Disease Activity and Cerebrovascular Function in Crohn's Disease
Crohn's disease is a chronic recurrent systemic inflammatory disease. Studies have shown that meat, dairy products, fiber and vitamin D may affect the risk of Crohn's disease. The relationship between other dietary components and disease activity or recurrence in Chron's disease has not been fully studied. Although the patient's diet will affect the degree of disease activity, there is still no recognized daily diet model for CD patients. At present, the change of intestinal microbiome is considered to be one of the causes of IBD, and this change provides a theoretical basis for diet to reduce the inflammatory response in CD patients through the regulation of microbiome. Food driven inflammation may affect the activity of the disease. Brain-gut axis interaction may play an important role in CD and may have an effect on the cerebrovascular system. The investigators aim to evaluate the effects of Empirical Dietary Inflammatory Pattern (EDIP) based dietary suggestions on disease activity and cerebrovascular function as well as changes of intestinal flora and its metabolites amongst Chron's disease participants of all ages.
NCT04736368 — Crohn Disease
Status: Not yet recruiting
http://inclinicaltrials.com/crohn-disease/NCT04736368/
Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)
Hypothesis:In patients with ulcerative colitis and Crohn's disease diagnosed with mild or moderate anaemia: 1. iron supplementation will increase disease activity and oxidative stress 2. the addition of antioxidant vitamin will reduce this detrimental effect
NCT00152841 — Ulcerative Colitis
Status: Terminated
http://inclinicaltrials.com/ulcerative-colitis/NCT00152841/