Durham, NC – Stem cells may provide Crohn’s disease sufferers relief from a common, potentially dangerous side effect – fistulas – according to the results of a phase 2 clinical trial published in the latest issue of STEM CELLS Translational Medicine (SCTM). After receiving an injection of their own adipose-derived stem cells (ASC), which are collected from fat tissue, the fistulas in 75 percent of the trial participants were completely healed within eight weeks of their last treatment and remained so two years later.
Crohn’s disease is a painful, chronic autoimmune disorder in which the body’s immune system attacks the gastrointestinal tract. Inflammation in Crohn’s patients can sometimes extend completely through the intestinal wall and create a fistula — an abnormal connection between the intestine and another organ or skin. Left untreated, a fistula might become infected and form an abscess, which in some cases can be life threatening.
Chang Sik Yu, M.D., Ph.D., of Asan Medical Center in Seoul, Korea, a senior author of the SCTM paper, describes the results of a clinical trial conducted in collaboration with four other hospitals in South Korea, “Crohn’s fistula is one of the most distressing diseases as it decreases patient’s quality of life and frequently recurs. It has been reported to occur in up to 38 percent of Crohn’s patients and over the course of the disease, 10 to 18 percent of them must undergo a proctectomy, which is a surgical procedure to remove the rectum.”
Overall, the treatments currently available for Crohn’s fistula remain unsatisfactory because they fail to achieve complete closure, lower recurrence and limit adverse effects, Dr. Yu said. Given the challenges and unmet medical needs in Crohn’s fistula, attention has turned to stem cell therapy as a possible treatment.
Several studies, including those undertaken by Dr. Yu’s team, suggest that mesenchymal stem cells (MSCs) do indeed improve Crohn’s disease and Crohn’s fistula. Their phase II trial involved 43 patients for a term of one year, over the period from January 2010 to August 2012. The results showed that 82 percent experienced complete closure of fistula eight weeks after the final ASC injection.
“It strongly demonstrated MSCs derived from ASCs are a safe and useful therapeutic tool for the treatment of Crohn’s fistula,” Dr. Yu said.
The latest study was intended to evaluate the long-term outcome by following 41 of the original 43 patients for yet another year. Dr. Yu reported, “Our long-term follow-up found that one or two doses of autologous ASC therapy achieved complete closure of the fistulas in 75 percent of the patients at 24 months, and sustainable safety and efficacy of initial response in 83 percent. No adverse events related to ASC administration were observed. Furthermore, complete closure after initial treatment was well sustained.”
“These results strongly suggest that autologous ASCs may be a novel treatment option for Crohn’s fistulae,” he said.
“Stem cells derived from fat tissue are known to regulate the immune response, which may explain these successful long-term results treating Crohn’s fistulae with a high risk of recurrence,” said Anthony Atala, M.D., Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine.
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