In the Journals

Novel stem cell therapy provides long-term treatment for Crohn's fistula

Long-term follow-up of patients with fistulae related to Crohn’s disease demonstrated sustained complete closure after autologous adipose-derived stem cell therapy, according to research data.

“Crohn’s fistula is one of the most distressing diseases as it decreases [a] patient’s quality of life and frequently recurs,” Chang Sik Yu, MD, PhD, from Asan Medical Center in Seoul, Korea, said in a press release. “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.”

Currently available treatments fail to achieve complete closure or reduce recurrence and adverse events, he added.

In a previous phase 2 clinical trial involving 43 patients with Crohn’s fistula, Yu and colleagues demonstrated that mesenchymal stem cells derived from adipose tissue were safe and had therapeutic potential, with 82% of patients achieving complete healing with sustained response for 1 year.

“It strongly demonstrated [mesenchymal stem cells] derived from [adipose-derived stem cells] are a safe and useful therapeutic tool for the treatment of Crohn’s fistula,” Yu said.

Yu and colleagues then performed a retrospective study to assess long-term outcomes. Included in the intention-to-treat analysis were 41 patients (68.3% male; mean age, 26.2 ± 5.5 years) who were followed for an additional year at five South Korean hospitals from January 2010 to August 2012, all of whom had received either one or two adipose-derived stem cell injections into the tract of the fistulae in the initial study.

In the modified per protocol analysis, 79.3% of patients had complete healing at 12 months and 80.8% had complete healing at 24 months. In the modified intention-to-treat analysis 80% showed complete response at 12 months and 75% at 24 months. Of the 24 patients with complete closure at week 8 who were studied for durability, 83.3% had sustained complete closure at 24 months. No adverse events related to treatment occurred.

“These results strongly suggest that autologous [adipose-derived stem cells] may be a novel treatment option for Crohn’s fistulae,” Yu 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,” Anthony Atala, MD, editor-in-chief of Stem Cells Translational Medicine, and director of the Wake Forest Institute for Regenerative Medicine, said in the release. – by Adam Leitenberger

Disclosure: Yu reports he is an employee of Anterogen Co Ltd. Please see the full study for a  list of all other researchers relevant financial disclosures.

Long-term follow-up of patients with fistulae related to Crohn’s disease demonstrated sustained complete closure after autologous adipose-derived stem cell therapy, according to research data.

“Crohn’s fistula is one of the most distressing diseases as it decreases [a] patient’s quality of life and frequently recurs,” Chang Sik Yu, MD, PhD, from Asan Medical Center in Seoul, Korea, said in a press release. “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.”

Currently available treatments fail to achieve complete closure or reduce recurrence and adverse events, he added.

In a previous phase 2 clinical trial involving 43 patients with Crohn’s fistula, Yu and colleagues demonstrated that mesenchymal stem cells derived from adipose tissue were safe and had therapeutic potential, with 82% of patients achieving complete healing with sustained response for 1 year.

“It strongly demonstrated [mesenchymal stem cells] derived from [adipose-derived stem cells] are a safe and useful therapeutic tool for the treatment of Crohn’s fistula,” Yu said.

Yu and colleagues then performed a retrospective study to assess long-term outcomes. Included in the intention-to-treat analysis were 41 patients (68.3% male; mean age, 26.2 ± 5.5 years) who were followed for an additional year at five South Korean hospitals from January 2010 to August 2012, all of whom had received either one or two adipose-derived stem cell injections into the tract of the fistulae in the initial study.

In the modified per protocol analysis, 79.3% of patients had complete healing at 12 months and 80.8% had complete healing at 24 months. In the modified intention-to-treat analysis 80% showed complete response at 12 months and 75% at 24 months. Of the 24 patients with complete closure at week 8 who were studied for durability, 83.3% had sustained complete closure at 24 months. No adverse events related to treatment occurred.

“These results strongly suggest that autologous [adipose-derived stem cells] may be a novel treatment option for Crohn’s fistulae,” Yu 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,” Anthony Atala, MD, editor-in-chief of Stem Cells Translational Medicine, and director of the Wake Forest Institute for Regenerative Medicine, said in the release. – by Adam Leitenberger

Disclosure: Yu reports he is an employee of Anterogen Co Ltd. Please see the full study for a  list of all other researchers relevant financial disclosures.