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A Phase I Clinical Trial of the Treatment of Crohn's Fistula by Adipose Mesenchymal Stem Cell Transplantation
Abstract
PURPOSE: The effective management of fistulas in patients with Crohn's disease presents an extremely challenging problem. Mesenchymal adult stem cells extracted from certain tissues, such as adipose tissue, can differentiate into various cell types. Therefore, we have tried to use such cells to stimulate healing of Crohn's fistulas. METHODS: We designed a prospective Phase I clinical trial, involving five patients with Crohn's disease, to test the feasibility and safety of autologous stem cells transplantation in the treatment of fistulas. We also studied the expression of various cell markers and the growth rates of the lipoaspirate-derived cells that were used for transplantation. RESULTS: One patient was excluded because of bacterial contamination of cultured cells. We inoculated nine fistulas in four patients with autologous adipose tissue-derived stem cells at Passage 3 or earlier. Eight inoculated fistulas were followed weekly for at least eight weeks. In six fistulas, the external opening was covered with epithelium at the end of Week 8, and, thus, these fistulas were considered healed (75 percent). In the other two fistulas, there was only incomplete closure of the external opening, with a decrease in output flow (not healed; 25 percent). No adverse effects were observed in any patient at the end of the follow-up period (minimum follow-up,12 months; maximum follow-up, 30 months; follow-up average, 22 months). CONCLUSIONS: To our knowledge, this is the first report of a clinical trial of cell therapy using autologous stem cells obtained from a lipoaspirate. Our results indicate that our protocol is feasible and safe for the treatment of fistulas in Crohn's disease. The number of patients included and the uncontrolled nature of Phase I clinical trials do not allow demonstration of the effectiveness of the treatment. However, the results of the present study encourage to perform further studies in Phase II.
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Cited by
Mesenchymal stem cells and immunomodulation: current status and future prospects
Gao, F., Chiu, S. M., Motan, D. A. L., Zhang, Z., Chen, L., Ji, H.-L., Tse, H.-F., Fu, Q.-L., & Lian, Q. (2016) · Cell Death & Disease · doi:10.1038/cddis.2015.327 · Cited by 1,121
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) · Diseases of the Colon & Rectum · doi:10.1007/dcr.0b013e3181973487 · Cited by 773
Self-citationMesenchymal stem cells: a new strategy for immunosuppression and tissue repair
Shi, Y., Hu, G., Su, J., Li, W., Chen, Q., Shou, P., Xu, C., Chen, X., Huang, Y., Zhu, Z., et al. (2010) · Cell Research · doi:10.1038/cr.2010.44 · Cited by 575
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
Lanzoni, G., Linetsky, E., Correa, D., Messinger Cayetano, S., Alvarez, R. A., Kouroupis, D., Alvarez Gil, A., Poggioli, R., Ruiz, P., Marttos, A. C., et al. (2021) · Stem Cells Translational Medicine · doi:10.1002/sctm.20-0472 · Cited by 404
Metadata
- Authors
- García-Olmo, D., García-Arranz, M., Herreros, D., Pascual, I., Peiro, C., & Rodríguez-Montes, J. A.
- Venue
- Diseases of the Colon & Rectum
- Published
- 2005-07
- Volume
- 48
- Issue
- 7
- Pages
- 1416-1423
- ISSN
- 0012-3706 (ISSN-L)
- OpenAlex
- W2133426555
- Cited by
- 799
- References
- 0
- FWCI
- 9.75
- Type
- journal article
- Language
- en
- Open access
- closed
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- García-Olmo, D., García-Arranz, M., Herreros, D., Pascual, I., Peiro, C., & Rodríguez-Montes, J. A. (2005). A Phase I Clinical Trial of the Treatment of Crohn's Fistula by Adipose Mesenchymal Stem Cell Transplantation. Diseases of the Colon & Rectum. https://doi.org/10.1007/s10350-005-0052-6
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