Fat-Derived Stem Cell Therapy for Inflammatory Bowel Disease

(ADcSVF-IBD Trial)

This trial tests a new treatment using fat-derived stem cells (AD-cSVF) to manage Inflammatory Bowel Disease (IBD), including conditions like Ulcerative Colitis and Crohn's Disease. The goal is to determine if these cells can repair the gut and reduce inflammation beyond the usual symptom-suppressing medications. Participants will receive various treatments involving these stem cells, and researchers will compare their effects. The study seeks individuals diagnosed with IBD for at least six months who can tolerate the trial procedures. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group of patients.

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently on corticosteroids and meet the criteria for cortico-dependency, you may not be eligible to participate.

Research has shown that treatments using fat-derived stem cells, such as AD-cSVF, have been studied for their safety in various conditions, including gut disorders like IBD. These cells have shown promise in treating gastrointestinal diseases such as IBD and colorectal cancer, suggesting they might be well-tolerated.

One study highlighted that these fat-derived cells are easy to obtain and may aid in blood vessel growth and immune system balance, potentially leading to fewer side effects for patients.

Additionally, over 160 trials have used these cells for different diseases, with safety as a key focus. While not all trials specifically address IBD, their widespread use in medical research suggests a favorable safety profile.

Unlike the standard of care for inflammatory bowel disease, which often involves medications like anti-inflammatory drugs, immune system suppressors, or biologics, the AD-cSVF treatment is derived from a patient’s own fat tissue. Researchers are excited about this treatment because it harnesses adipose-derived stem cells, which have the potential to reduce inflammation and promote tissue repair in a natural way. This approach could offer a more targeted and personalized treatment option with fewer side effects, as it uses the body’s own regenerative cells. Additionally, the method of isolating and delivering these cells is unique, potentially allowing for more rapid and effective relief from symptoms compared to conventional therapies.

Research has shown that fat-derived stem cells, known as AD-cSVF, may help treat inflammatory bowel disease (IBD). Studies have found that these cells can effectively address digestive issues, including IBD, by reducing inflammation and repairing damaged tissue. In this trial, participants in the AD-cSVF Arm 2 will receive isolated cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction. Meanwhile, participants in the Lipoaspiration Arm 1 will undergo acquisition of adipose-derived tissue stromal vascular fraction (AD-tSVF) via closed syringe harvest subdermal fat. Specifically, patients with complex anal fistulas, a common problem in Crohn's disease, showed improvement after receiving these stem cells. This suggests that AD-cSVF might help manage symptoms and improve the quality of life for people with IBD.¹³⁶⁷⁸