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P362. Autologous haematopoietic stem cell transplantation without CD34+ cell selection for refractory Crohn's disease: The Milan experience after 5 years

A. Cassinotti1, F. Onida2, C. Annaloro2, G. Sampietro3, P. Fociani4, M. Fichera1, G. Maconi1, M. Lombardini1, C. Bezzio1, D. Foschi3, G. Lambertenghi Deliliers2, G. Bianchi Porro1, R. De Franchis1, S. Ardizzone1

1L. Sacco University Hospital, Department of Gastroenterology, Milan, Italy; 2Ospedale Policlinico, Milan, Italy; 3L. Sacco University Hospital, Department of Surgery II, Milan, Italy; 4L. Sacco University Hospital, Department of Pathology, Milan, Italy

Background: Autologous haematopoietic stem cell transplantation (HSCT) has recently been used to treat refractory Crohn's disease (CD). We updated our first experience with unselected stem cell autotransplantation in refractory CD.

Methods: Ten patients (4 male, age 22–46 years) with active moderate-severe CD (median CDAI 340, range 236–395; four with perianal disease), refractory or intolerant to multiple drugs including anti-TNF-alpha agents and immunosuppressors, were enrolled. Unselected PBSCs were collected after mobilisation with CTX 1.5 g/m2 and G‑CSF 10 mcg/kg. The conditioning regimen included CTX 50 mg/kg on days −5 to −2 and rabbit ATG 2.5 mg/kg on days −4 to −2. Toxicity, clinical remission (CDAI <150), endoscopic remission (SES-CD) and extramucosal response (ultrasound sonography [US]) were assessed after mobilisation and at 3, 12 months and then every year after stem cells reinfusion.

Results: No improvement was confirmed after mobilisation (median CDAI 364, range 201–404). Eight patients were in clinical remission at the first month (median CDAI 141, range 90–198). At the third month, all patients were in clinical remission (median CDAI 91, range 56–132) despite discontinuation of all medications. After a median follow-up of 56 (range 23–68) months, clinical remission was maintained in 80%, 50%, 40%, 30% and 30% at the 1st, 2nd, 3rd, 4th and 5th year after HSCT, respectively. Complete mucosal healing was observed in 50% and 60% after 3 and 12 months, respectively, but maintained in only 30% at their last visit. Perianal fistulas closure was observed in 3/4 patients. No deaths or life-threatening infections occurred. Unexpected adverse events included a perianal abscess after mobilisation in one patient, pleural and pericardial effusions in another, BK virus-related macrohaematuria in one case, and acute pielonephritis in another patient, all rapidly resolved with conservative treatment.

Conclusions: Unselected CD34+ cells transplantation can induce and maintain both clinical and endoscopic remission in refractory CD patients.