Page 26 - 83_04
P. 26

Clinical applications of adipose-derived stem cells and aspects related with good manufacturing practices

     derived stem cell therapy and bone marrow progenitor          Marrow-Derived Mesenchymal Stromal Cells
     recruitment in ischemic heart. Lab Investig.                  Promote Healing of Refractory Perianal Fistulas in
     2011;91(4):539–52.                                            Patients With Crohn’s Disease. Gastroenterology.
                                                                   2015;149(4):918–27.
30. Mazo M, Gavira JJ, Pelacho B. Adipose-derived Stem
     Cells for Myocardial Infarction. J Cardiovasc Transl     44. De la Portilla F, Alba F, García-Olmo D, Herrerías
     Res. 2011;4(2):145–53.                                        JM, González FX, Galindo A. Expanded allogeneic
                                                                   adipose-derived stem cells ( eASCs ) for the treatment
31. Koh YG, Choi YJ. Infrapatellar fat pad-derived                 of complex perianal fistula in Crohn ’ s disease:
     mesenchymal stem cell therapy for knee osteoarthritis.        results from a multicenter phase I / IIa clinical trial.
     Knee. 2012;19(6):902–7.                                       Int J Color Dis. 2013;28(3):313–23.

32. Koh YG, Choi YJ, Kwon SK, Kim YS, Yeo JE.                 45. National Institutes of Health. ClinicaTrials.gov.
     Clinical results and second-look arthroscopic findings        Registry and results database of publicly and privately
     after treatment with adipose-derived stem cells for           supported clinical studies of human participants
     knee osteoarthritis. Knee Surg Sport Traumatol                conducted around the world. 2013.
     Arthrosc. 2013;23(5):1308–16.
                                                              46. WHO Technical Report Series No. 908. WHO Good
33. Loma I, Heyman R. Multiple Sclerosis: Pathogenesis             manufacturing practices for pharmaceutical products:
     and Treatment. Curr Neuropharmacol. 2011;9(3):409–            main principles, Annex 2. Geneva; 2014.
     16.
                                                              47. 21 C.F.R. § 1271.3. 2016.
34. Ghasemi N. Therapeutic effects of adipose derived
     mesenchymal stem cells on remyelination process in       48. Larijani B, Aghayan H, Goodarzi P, Mohamadi-Jahani
     inflammatory demyelinating diseases. J Histol                 F, Norouzi-Javidan A, Reza Dehpour A, et al. Clinical
     Histopathol. 2015;2(1):1–8.                                   Grade Human Adipose Tissue-Derived Mesenchymal
                                                                   Stem Cell Banking. Acta Med Iran. 2015;53(9):540–6.
35. Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet.
     2012;380(9853):1590–605.                                 49. 21 C.F.R. §1271 Subpart D. 2017.

36. Scharl M, Rogler G. Pathophysiology of fistula            50. European Commission. Regulation (EC) No
     formation in Crohn’s disease. World J Gastrointest            1394/2007 of The European Parliament and of the
     Pathophysiol. 2014;5(3):205–12.                               Council of 13 November 2007 on advanced therapy
                                                                   medicinal products and amending Directive
37. Cao Y, Ding Z, Han C, Shi H, Cui L. Efficacy of                2001/83/EC and Regulation (EC) No 726/2004. Off J
     Mesenchymal Stromal Cells for Fistula Treatment of            Eur Union. 2007;50:121–37.
     Crohn ’ s Disease: A Systematic Review and Meta-
     Analysis. Dig Dis Sci. 2017;62(4):851–60.                51. Sensebé L, Gadelorge M, Fleury-Cappellesso S.
                                                                   Production of mesenchymal stromal / stem cells
38. García-Olmo D, García-Arranz M, Herreros D,                    according to good manufacturing practices?: a review.
     Pascual I, Peiro C, Rodríguez-Montes JA. A phase I            Stem Cell Res Ther. 2013;4(3):66–71.
     clinical trial of the treatment of crohn’s fistula by
     adipose mesenchymal stem cell transplantation. Dis       52. Commission Directive 2006/17/EC. Implementing
     Colon Rectum. 2005;48(7):1416–23.                             Directive 2004/23/EC of the European Parliament and
                                                                   of the Council as regards certain technical
39. Garcia-Olmo D, Herreros D, Pascual I, Pascual J, Del-          requirements for the donation, procurement and
     Valle E, Zorrilla J, et al. Expanded adipose-derived          testing of human tissues and cells. 2006.
     stem cells for the treatment of complex perianal
     fistula: a phase II clinical trial. Dis Colon Rectum.    53. Gimble JM, Guilak F, Bunnell BA. Clinical and
     2009;52(1):79–86.                                             preclinical translation of cell-based therapies using
                                                                   adipose tissue-derived cells. Stem Cell Res Ther.
40. García-Olmo D, Herreros D, Pascual M, Pascual I,               2010;1(2):19–26.
     De-La-Quintana P, Trebol J, et al. Treatment of
     enterocutaneous fistula in Crohn’s Disease with          54. Zhu M, Heydarkhan-Hagvall S, Hedrick M, Benhaim
     adipose-derived stem cells: a comparison of protocols         P, Zuk P. Manual Isolation of Adipose-derived Stem
     with and without cell expansion. Int J Colorectal Dis.        Cells from Human Lipoaspirates. J Vis Exp.
     2009;24(1):27–30.                                             2013;79:1–10.

41. Panés J, García-Olmo D, Van Assche G, Colombel JF,        55. ISO14644-1. Clean rooms and associated controlled
     Reinisch W, Baumgart DC, et al. Expanded allogeneic           environments. Part 1: Classification of airborne
     adipose-derived mesenchymal stem cells (Cx601) for            particles. Geneva; 1999.
     complex perianal fistulas in Crohn’s disease: a phase 3
     randomised, double-blind controlled trial. Lancet.       56. WHO Technical Report Series No 961. WHO good
     2016;388(10051):1281–90.                                      manufacturing practices for sterile pharmaceutical
                                                                   products, Annex 6. 2011.
42. Defrancesco L, Lilly BE. Drug pipeline: 2Q17. Nature
     Biotechnology. 2017; 8;35(8):703.                        57. WHO Technical Report Series No. 996. WHO good
                                                                   manufacturing practices for biological products,
43. Molendijk I, Bonsing BA, Roelofs H, Peeters KCMJ,              Annex 3. Geneva; 2016.
     Wasser MNJM, Dijkstra G, et al. Allogeneic Bone
                                                              58. Committee for Medicinal Products for Human Use.

@Real Academia Nacional de Farmacia. Spain                                                                 401
   21   22   23   24   25   26   27   28   29   30   31