A phase 2 study of allogeneic mesenchymal stromal cells for luminal crohn's disease refractory to biologic therapy

Clinical Gastroenterology and Hepatology

Volumn 12, Issue 1, 2014, Pages 64-71

  Forbes, Geoffrey M ^a,b   Sturm, Marian J ^a,c   Leong, Rupert W ^e   Sparrow, Miles P ^f   Segarajasingam, Dev ^g   Cummins, Adrian G ^h   Phillips, Michael ^d   Herrmann, Richard P ^a,c  

^a ROYAL PERTH HOSPITAL   (Australia)

^b UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^c UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^d UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^e Department of Microbiology and Infectious Diseases   (Australia)

^f ALFRED HOSPITAL   (Australia)

^g SIR CHARLES GAIRDNER HOSPITAL   (Australia)

^h QUEEN ELIZABETH HOSPITAL   (Australia)

Author keywords

Autoimmune; Cellular Therapy; Immune Response; Inflammation; Intestine

Indexed keywords

ADALIMUMAB; ALANINE AMINOTRANSFERASE; AZATHIOPRINE; C REACTIVE PROTEIN; INFLIXIMAB; MERCAPTOPURINE;

ADENOCARCINOMA; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALLOGENEIC STEM CELL TRANSPLANTATION; ARTICLE; BIOLOGICAL THERAPY; CLINICAL ARTICLE; CROHN DISEASE; DISEASE ACTIVITY; DYSGEUSIA; FEMALE; HEADACHE; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; LYMPHOCYTOPENIA; MALE; MESENCHYMAL STROMA CELL; NAUSEA; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; QUALITY OF LIFE; REMISSION; TREATMENT RESPONSE; VAGINA CANDIDIASIS; ADVERSE EFFECTS; ALLOTRANSPLANTATION; CELL TRANSPLANTATION; CLINICAL TRIAL; MIDDLE AGED; MULTICENTER STUDY; PHYSIOLOGY; PROCEDURES; PSYCHOLOGY; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; C-REACTIVE PROTEIN; CELL TRANSPLANTATION; CROHN DISEASE; FEMALE; HUMANS; MALE; MESENCHYMAL STROMAL CELLS; MIDDLE AGED; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TRANSPLANTATION, HOMOLOGOUS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84890190232     PISSN: 15423565     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cgh.2013.06.021     Document Type: Article

References (22)

1. Bouguen G., Peyrin-Biroulet L. Surgery for adult Crohn's disease: what is the actual risk?. Gut 2011, 60:1178-1181.
2. Hommes D.W., Duijvestein M., Zelinkova Z., et al. Long-term follow-up of autologous hematopoietic stem cell transplantation for severe refractory Crohn's disease. JCrohns Colitis 2011, 5:543-549.
3. Le Blanc K., Tammik C., Rosendahl K., et al. HLA expression and immunologic properties of differentiated and undifferentiated mesenchymal stem cells. Exp Hematol 2003, 31:890-896.
4. Le Blanc K., Frassoni F., Ball L., et al. Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet 2008, 371:1579-1586.
5. Herrmann R., Sturm M., Shaw K., et al. Mesenchymal stromal cell therapy for steroid-refractory acute and chronic graft versus host disease: a phase 1 study. Int J Hematol 2012, 95:182-188.
6. Figueroa F.E., Carrion F., Villanueva S., et al. Mesenchymal stem cell treatment for autoimmune diseases: a critical review. Biol Res 2012, 45:269-277.
7. Garcia-Olmo D., Herreros D., Pascual I., et al. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum 2009, 52:79-86.
8. Ciccocioppo R., Bernardo M.E., Sgarella A., et al. Autologous bone marrow-derived mesenchymal stromal cells in the treatment of fistulising Crohn's disease. Gut 2011, 60:788-798.
9. Duijvestein M., Vos A.C., Roelofs H., et al. Autologous bone marrow-derived mesenchymal stromal cell treatment for refractory luminalCrohn's disease: results of a phase I study. Gut 2010, 59:1662-1669.
10. Onken J, Gallup D, Hanson J, etal. Successful outpatient treatment of refractory Crohn's disease using adult mesenchymal stem cells. Available at: Accessed February 10,2013. http://www.osiris.com/pdf/Crohn's_Ph_II_Handout.pdf.
11. Mary J.Y., Modligliani R. Development and validation of an endoscopic index of the severity for Crohn's disease. Group d'Etudes Therapeutiques des Affections Inflammatoires du Tube Digestif (GETAID). Gut 1989, 30:983-989.
12. Irvine E.J., Feagan B., Rockon J., et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Gastroenterology 1994, 106:287-296.
13. AQoL. Assessment of Quality of Life. Available at: Accessed February 10,2013. http://www.aqol.com.au.
14. Dominici M., Le Blanc K., Mueller I., et al. Minimal criteria for definingmultipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 2006, 8:315-317.
15. Burt R.K., Craig R.M., Milanetti F., et al. Autologous non-myeloablative hematopoietic stem cell transplantation in patients with severe anti-TNF refractory Crohn's disease: long-term follow-up. Blood 2010, 116:6123-6132.
16. Hawkey C., Allez M., Ardizzone S., et al. Clinical and endoscopic improvement following hemopoietic stem cell transplantation in the ASTIC trial. JCrohn's Colitis 2013, 7(Suppl 1):S4.
17. Newman R.E., Yoo D., Le Roux M.A., et al. Treatment of inflammatory diseases with mesenchymal stem cells. Inflamm Allergy Drug Targets 2009, 8:110-123.
18. Forslow U., Blennow O., Le Blanc K., et al. Treatment with mesenchymal stromal cells is a risk factor for pneumonia-related death after allogeneic haematopoietic stem cell transplantation. Eur J Haematol 2012, 89:220-227.
19. Mishra P.J., Mishra P.J., Glod J.W., et al. Mesenchymal stem cells: flip side of the coin. Cancer Res 2009, 69:1255-1256.
20. Onken J., Jaffe T., Custer L. Long-term safety of prochymal adult mesenchymal stem cells in Crohn's disease. Gastroenterology 2008, 134:A661.
21. Brand S. Crohn's disease: Th1, Th17 or both? The change of a paradigm: new immunological and genetic insights implicate Th17 cells in the pathogenesis of Crohn's disease. Gut 2009, 58:1152-1167.
22. Galipeau J. The mesenchymal stromal cell dilemma-does a negative phase III trial of random donor mesenchymal stromal cells in steroid-resistant graft-versus-host disease represent a death knell or a bump in the road?. Cytotherapy 2013, 15:2-8.