Autologous Mesenchymal Stem Cells, Applied in a Bioabsorbable Matrix, for Treatment of Perianal Fistulas in Patients With Crohn's Disease

被引:174
作者
Dietz, Allan B. [1 ]
Dozois, Eric J. [2 ]
Fletcher, Joel G. [3 ]
Butler, Greg W. [1 ]
Radel, Darcie [1 ]
Lightner, Amy L. [2 ]
Dave, Maneesh [4 ]
Friton, Jessica [5 ]
Nair, Asha [6 ]
Camilleri, Emily T. [7 ]
Dudakovic, Amel [7 ]
Van Wijnen, Andre J. [7 ]
Faubion, William A. [5 ]
机构
[1] Mayo Clin, Dept Lab Med & Pathol, 200 First St SW, Rochester, MN 55905 USA
[2] Mayo Clin, Dept Colon & Rectal Surg, Rochester, MN USA
[3] Mayo Clin, Dept Radiol, Rochester, MN USA
[4] Case Western Reserve Univ, Sch Med, Div Gastroenterol & Liver Dis, Cleveland, OH USA
[5] Mayo Clin, Div Gastroenterol & Hepatol, 200 First St SW, Rochester, MN 55905 USA
[6] Mayo Clin, Dept Biomed Stat & Informat, Rochester, MN USA
[7] Mayo Clin, Dept Orthoped Surg, Rochester, MN USA
基金
美国国家卫生研究院;
关键词
STOMP Trial; IBD; Cell Therapy; Clinical Trial; SAFETY; TRIAL;
D O I
10.1053/j.gastro.2017.04.001
中图分类号
R57 [消化系及腹部疾病];
学科分类号
100201 [内科学];
摘要
In patients with Crohn's disease, perianal fistulas recur frequently, causing substantial morbidity. We performed a 12-patient, 6-month, phase 1 trial to determine whether autologous mesenchymal stem cells, applied in a bio-absorbable matrix, can heal the fistula. Fistula repair was not associated with any serious adverse events related to mesenchymal stem cells or plug placement. At 6 months, 10 of 12 patients (83%) had complete clinical healing and radiographic markers of response. We found placement of mesenchymal stem cellLcoated matrix fistula plugs in 12 patients with chronic perianal fistulas to be safe and lead to clinical healing and radiographic response in 10 patients. ClinicalTrials.gov Identifier: NCT01915927.
引用
收藏
页码:59 / +
页数:6
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