Patients with Crohn’s fistula may benefit from therapy with autologous adipose-derived stem cells (ASCs), according to the results of a phase 2 clinical trial conducted by five medical institutions in collaboration with Anterogen Co., Ltd., in Korea. No adverse effects and a benefit in nearly all patients a year after treatment indicates treatment was a success.
“It strongly demonstrated [mesenchymal stem cells (MSCs)] derived from ASCs are a safe and useful therapeutic tool for the treatment of Crohn’s fistula,” said principal investigator Dr. Chang Sik Yu, in a news release from the publishing journal. The article, “Long-Term Results of Adipose-Derived Stem Cell Therapy for the Treatment of Crohn’s Fistula,” was published in Stem Cells Translational Medicine.
The current study was a follow-up to the phase 2 clinical trial that injected self-donor fat-derived ASCs into 43 patients who had Crohn’s fistula, or abnormal connections between the intestines and other organs or skin that can eventually lead to life-threatening infections and abscesses. These fistulas are the result of inflammation in Crohn’s disease that extends completely through the gastrointestinal wall. Since fistulas are caused by inflammation, the team believed MSCs, which are notoriously anti-inflammatory, could help initiate healing.
Patients underwent an ASC collection procedure, and scientists grew the ASCs into MSCs. Doctors then injected MSCs back into the patients and followed the patients for one year. In 82% of patients, fistulas were completely healed after eight weeks of the last treatment. The team followed 41 these patients for another year and found that 75% had a sustained response.
“Our long-term follow-up found that one or two doses of autologous ASC therapy achieved complete closure of the fistulas in 75% of the patients at 24 months, and sustainable safety and efficacy of initial response in 83%,” said Dr. Yu. “No adverse events related to ASC administration were observed. Furthermore, complete closure after initial treatment was well sustained.”
This is great news for patients with Crohn’s fistula, who are currently treated with unsatisfactory therapies associated with recurrence and adverse events. “Crohn’s fistula is one of the most distressing diseases as it decreases patient’s quality of life and frequently recurs,” explained Dr. Yu. “It has been reported to occur in up to 38% of Crohn’s patients and over the course of the disease, 10 to 18% of them must undergo a proctectomy, which is a surgical procedure to remove the rectum.” Hopefully, the results of this phase 2 clinical trial will bring another treatment option to Crohn’s fistula patients.
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