Original articleLong-Term Follow-Up of Crohn Disease Fistulas After Local Injections of Bone Marrow–Derived Mesenchymal Stem Cells
Section snippets
Study Population and Protocol
Starting from January 10, 2007, through June 30, 2014, 10 patients with CD who had undergone serial intrafistular injections of autologous bone marrow–derived MSCs (median, 4; range, 2-5; scheduled at 4-week intervals) as compassionate use for patients with refractory disease or inability to undergo standard therapies12 were prospectively enrolled in this study. The study parameters, including careful clinical and perianal examination, routine laboratory tests, and calculation of the CDAI,14
Long-Term Outcome and Management
A total of 8 (median age, 37 years; range, 21-64 years) of the 10 patients who completed the first 12-month follow-up period after the end of treatment with serial local injections of autologous bone marrow–derived MSCs for refractory fistulizing CD12 were available for the further 5-year assessment. Their demographic and clinical features are presented in the Table. As regards fistula localization, 7 had complex perianal fistulas, whereas the remaining patient (no. 4) had had multiple
Discussion
Over the past decade, great efforts have been made to improve and standardize the complex management of fistulizing CD, which is now based on a balanced use of both medical and surgical approaches.18 In this regard, the availability of new tools such as several biological agents and an array of specific procedures such as mucosal advancement flap, muscle transposition, ligation of the intersphincteric fistula tract, and the use of bioprosthetic plugs or fibrin glue18 have made the treatment of
Conclusion
Our evidence opens up several issues in the use of local injections of MSCs for Crohn fistulas that have important implications for physicians and patients. First, this treatment option seems highly efficacious in refractory conditions in the short term and the medium term (up to 12 months), thus rescuing the patients from severely disabling symptoms. Nevertheless, most of the patients relapse to varying extents at later time points, but regain responsiveness to drugs that had previously proved
Acknowledgment
We are grateful to Ms Sheila McVeigh for her thorough revision of the English text.
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Cited by (0)
Grant Support: This study was financed by grants (R.C.) from the IRCCS San Matteo Hospital Foundation (Progetti di Ricerca Corrente), project titled “Studio immunofenotipico e funzionale delle cellule stromali mesenhimali midollari di pazienti affetti da malattie infiammatorie croniche intestinali,” (project no: 08064409) and Ministero dell’Istruzione, dell’Università e della Ricerca (Progetti di Rilevante Interesse Nazionale), project titled “Study of immunomodulatory and immunosuppressive effects of mesenchymal stem cells on T lymphocytes of patients with Crohn’s disease” (prot. 2010K34C45_007).