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Randomized Controlled Trial
. 2016 Sep;65(9):1456-62.
doi: 10.1136/gutjnl-2015-309836. Epub 2015 Nov 19.

Improving safety of autologous haematopoietic stem cell transplantation in patients with Crohn's disease

Aranzazu Jauregui-Amezaga  1 , Montserrat Rovira  2 , Pedro Marín  3 , Azucena Salas  1 , Susana Pinó-Donnay  1 , Faust Feu  1 , J Ignasi Elizalde  1 , Francesc Fernández-Avilés  2 , Carmen Martínez  2 , Gonzalo Gutiérrez  2 , Laura Rosiñol  2 , Enric Carreras  2 , Alvaro Urbano  2 , Miguel Lozano  3 , Joan Cid  3 , María Suárez-Lledó  2 , Josep Mensa  4 , Jordi Rimola  5 , Sonia Rodríguez  5 , Mari Carme Masamunt  1 , Dolors Comas  1 , Irene Ruíz  2 , Anna Ramírez-Morros  1 , Marta Gallego  1 , Ingrid Ordás  1 , Julian Panés  1 , Elena Ricart  1
Affiliations
Randomized Controlled Trial

Improving safety of autologous haematopoietic stem cell transplantation in patients with Crohn's disease

Aranzazu Jauregui-Amezaga et al. Gut. 2016 Sep.

Abstract

Objective: To evaluate the feasibility and toxicity of autologous haematopoietic stem cell transplantation (HSCT) for the treatment of refractory Crohn's disease (CD).

Design: In this prospective study, patients with refractory CD suffering an aggressive disease course despite medical treatment, impaired quality of life and in whom surgery was not an acceptable option underwent HSCT. Toxicity and complications during the procedure and within the first year following transplantation were evaluated, along with the impact of the introduction of supportive measures on safety outcomes.

Results: 26 patients were enrolled. During mobilisation, 16 patients (62%) presented febrile neutropaenia, including one bacteraemia and two septic shocks. Neutropaenia median time after mobilisation was 5 days. 5 patients withdrew from the study after mobilisation and 21 patients entered the conditioning phase. Haematopoietic recovery median time for neutrophils (>0.5×10(9)/L) was 11 days and for platelets (>20×10(9)/L) 4 days. Twenty patients (95%) suffered febrile neutropaenia and three patients (27%) presented worsening of the perianal CD activity during conditioning. Among non-infectious complications, 6 patients (28.5%) presented antithymocyte globulin reaction, 12 patients (57%) developed mucositis and 2 patients (9.5%) had haemorrhagic complications. Changes in supportive measures over the study, particularly antibiotic prophylaxis regimes during mobilisation and conditioning, markedly diminished the incidence of severe complications. During the first 12-month follow-up, viral infections were the most commonly observed complications, and one patient died due to systemic cytomegalovirus infection.

Conclusions: Autologous HSCT for patients with refractory CD is feasible, but extraordinary supportive measures need to be implemented. We suggest that this procedure should only be performed in highly experienced centres.

Keywords: BONE MARROW TRANSPLANTATION; CROHN'S DISEASE; IBD CLINICAL; IMMUNOLOGY; INFLAMMATORY BOWEL DISEASE.

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