Abstract
Purpose
In patients with perianal fistulas, administration of adult stem cells (ASCs) derived from liposuction samples has proved a promising technique in a preceding phase II trial. We aimed to extend follow-up of these patients with this retrospective study.
Method
Patients who had received at least one dose of treatment (ASCs plus fibrin glue or fibrin glue alone) were included. Adverse events notified since the end of the phase II study were recorded. Clinical and magnetic resonance imaging (MRI) criteria were used to determine whether recurrence of the healed fistula had occurred.
Results
Data were available for 21 out of 24 patients treated with ASCs plus fibrin glue and 13 out of 25 patients treated with fibrin glue in the phase II study. Follow-up lasted a mean of 38.0 and 42.6 months, respectively. Two adverse events unrelated to the original treatment were reported, one in each group. There were no reports of anal incontinence associated with the procedure. Of the 12 patients treated with ASCs plus fibrin glue who were included in the retrospective follow-up in the complete closure group, only 7 remained free of recurrence. MRI was done in 31 patients. No relationship was detected between MRI results and the clinical fistula status, independent of the treatment received.
Conclusions
Long-term follow-up reaffirmed the very good safety profile of the treatment. Nevertheless, a low proportion of the stem cell-treated patients with closure after the procedure remained free of recurrence after more than 3 years of follow-up.
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Acknowledgments
The authors thank the following colleagues for their invaluable help during the course of this study: Dr. José Antonio Pascual, M.D. (Department. of Surgery, Doce de Octubre University Hospital, Madrid, Spain), Dr. Emilio Del-Valle, M.D., and Dr. Jaime Zorrilla, M.D. (Department of Surgery, Gregorio Marañón University Hospital, Madrid, Spain) for their assistance in the patient follow-up; Dr. Jorge Alemany, Dr. Maria Pascual, and Dr. Gemma Fernandez (Cellerix S.A., Madrid) for their contribution to the initial design; and Dr. Gregory Morley for the editorial support.
Financial disclosure and conflicts of interest
This clinical trial has been sponsored by Cellerix S.L. Damian García-Olmo is a holder of the UAM–Cellerix Chair of Cell Therapy and Regenerative Medicine to which Cellerix contributes 40,000€ per year. UAM and Cellerix S.A. share patent rights to Cx401. García-Olmo is a member of the advisory board of Cellerix S.A. M. Garcia-Arranz and D. García-Olmo are inventors in two patents related to Cx401 entitled “Identification and isolation of multipotent cells from non-osteochondral mesenchymal tissue” (10157355957US) and “Use of adipose tissue-derived stromal stem cells in treating fistula” (US11/167061).
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The European Medicines Agency (EMA) granted Cx401 (autologous expanded adipose-derived adult stem cells—eASCs) “orphan drug” status in 2005 for the treatment of anal fistula (Orphan Designation EU Number EU/3/05/303).
This is a randomized clinical trial.
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Guadalajara, H., Herreros, D., De-La-Quintana, P. et al. Long-term follow-up of patients undergoing adipose-derived adult stem cell administration to treat complex perianal fistulas. Int J Colorectal Dis 27, 595–600 (2012). https://doi.org/10.1007/s00384-011-1350-1
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DOI: https://doi.org/10.1007/s00384-011-1350-1