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Stem Cells Aid Healing of Crohn's-Related Perianal Fistulas: Presented at DDW
By Em Brown
WASINGTON, DC -- May 28, 2007 -- Autologous fat-derived stem cell transplantation to the site of a nonhealing perianal fistula in patients with Crohn's disease or cryptoglandular disease results in a high rate of healing compared with standard treatment with fibrin glue, researchers reported here at Digestive Disease Week 2007 (DDW).
Principal investigator Damian Garcia-Olmo, PhD, La Paz University, Madrid, Spain, presented results of a phase 2 study of stem cell transplantation in 12 patients with complex perianal fistulae who received autologous mesenchymal stem cells expanded from fat tissue samples.
The study involved 49 patients with complex perianal fistulae randomised by the investigators to standard treatment with fibrin glue or to fibrin glue plus autologous stem cells delivered to the site of the lesion.
Treatment was repeated if lesions had not healed at 8 weeks. At the end of the second 8-week period, healing had taken place in 70.83% of patients who received stem cells and in 16% of those who received fibrin glue alone.
The stem cells stimulated immunoregulation and cell proliferation without resorbing the fibrin glue, Dr. Garcia-Olmo said in a presentation on May 21st.
"Our main concern in this phase 2 study was safety [of treatment], and that was not a problem," he noted.
Some patients have been followed for up to 4 years and fistulas have not recurred. "This is fantastic!" Dr. Garcia-Olmo exclaimed. "[Autologous fat-derived stem cell transplantation is] very, very durable, and the stem cells stay where they are put."
He said phase 3 trials have already begun.
[Presentation title: Expanded Adipose-derived Stem Cells (Cx401) for the Treatment of Complex Perianal Fistula. A Phase II Clinical Trial. Abstract 492]
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