The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.
Expanded Adipose-Derived Stem Cells for the Treatment of Complex Perianal Fistula: a Phase II Clinical Trial
Abstract
PURPOSE: The feasibility and safety of stem cell-based therapy with expanded adipose-derived stem cells (ASCs) has been investigated in a phase I clinical trial. The present study was designed as a phase II multicenter, randomized controlled trial to further investigate the effectiveness and safety of ASCs in the treatment of complex perianal fistulas. METHODS: Patients with complex perianal fistulas (cryptoglandular origin, n = 35; associated with Crohn's disease, n = 14) were randomly assigned to intralesional treatment with fibrin glue or fibrin glue plus 20 million ASCs. Fistula healing and quality of life (SF-12 questionnaire) were evaluated at eight weeks and one year. If healing was not seen at eight weeks, a second dose of fibrin glue or fibrin glue plus 40 million ASCs was administered. RESULTS: Fistula healing was observed in 17 (71 percent) of 24 patients who received ASCs in addition to fibrin glue compared with 4 (16 percent) of 25 patients who received fibrin glue alone (relative risk for healing, 4.43; confidence interval, 1.74-11.27); P < 0.001). The proportion of patients with healing was similar in Crohn's and non-Crohn's subgroups. ASCs were also more effective than fibrin glue alone in patients with a suprasphincteric fistulous tract (P = 0.001). Quality of life scores were higher in patients who received ASCs than in those who received fibrin glue alone. At one year follow-up, the recurrence rate in patients treated with ASCs was 17.6 percent. Both treatments were well tolerated. CONCLUSION: Administration of expanded ASCs (20 to 60 million cells) in combination with fibrin glue is an effective and safe treatment for complex perianal fistula and appears to achieve higher rates of healing than fibrin glue alone.
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Cites
Multilineage Cells from Human Adipose Tissue: Implications for Cell-Based Therapies
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Human Adipose Tissue Is a Source of Multipotent Stem Cells
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Infliximab for the Treatment of Fistulas in Patients with Crohn's Disease
Present, D. H., Rutgeerts, P., Targan, S., Hanauer, S. B., Mayer, L., van Hogezand, R. A., Podolsky, D. K., Sands, B. E., Braakman, T., DeWoody, K. L., et al. (1999) · New England Journal of Medicine · doi:10.1056/nejm199905063401804 · Cited by 2,752
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Cited by
Lamb, C. A., Kennedy, N. A., Raine, T., Hendy, P. A., Smith, P. J., Limdi, J. K., Hayee, B., Lomer, M. C. E., Parkes, G. C., Selinger, C., et al. (2019) · Gut · doi:10.1136/gutjnl-2019-318484 · Cited by 2,346
The Potential of Adipose Stem Cells in Regenerative Medicine
Lindroos, B., Suuronen, R., & Miettinen, S. (2011) · Stem Cell Reviews and Reports · doi:10.1007/s12015-010-9193-7 · Cited by 441
Perianal fistulizing Crohn's disease: pathogenesis, diagnosis and therapy
Panés, J., & Rimola, J. (2017) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/nrgastro.2017.104 · Cited by 308
Review of the adipose derived stem cell secretome
Kapur, S. K., & Katz, A. J. (2013) · Biochimie · doi:10.1016/j.biochi.2013.06.001 · Cited by 305
Adipose-derived stromal cells: their identity and uses in clinical trials, an update
Casteilla, L. (2011) · World Journal of Stem Cells · doi:10.4252/wjsc.v3.i4.25 · Cited by 235
Metadata
- Authors
- Garcia-Olmo, D., Herreros, D., Pascual, I., Pascual, J. A., Del-Valle, E., Zorrilla, J., De-La-Quintana, P., Garcia-Arranz, M., & Pascual, M.
- Venue
- Diseases of the Colon & Rectum
- Published
- 2009-01
- Volume
- 52
- Issue
- 1
- Pages
- 79-86
- ISSN
- 0012-3706 (ISSN-L)
- OpenAlex
- W2041243709
- Cited by
- 773
- References
- 14
- FWCI
- 53.51
- Type
- journal article
- Language
- en
- Open access
- closed
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- Garcia-Olmo, D., Herreros, D., Pascual, I., Pascual, J. A., Del-Valle, E., Zorrilla, J., De-La-Quintana, P., Garcia-Arranz, M., & Pascual, M. (2009). Expanded Adipose-Derived Stem Cells for the Treatment of Complex Perianal Fistula: a Phase II Clinical Trial. Diseases of the Colon & Rectum. https://doi.org/10.1007/dcr.0b013e3181973487
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