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