Although adipose tissue and cells show considerable promise for clinical translation in the emerging field of regenerative medicine, they present a challenge to the regulatory community both nationally and internationally. This commentary evaluates the status of adipose-derived therapeutics and considers regulatory approaches designed to maximize patient safety while advancing clinical translation in accordance with evidence-based medical science.
Get full access to this article
View all access options for this article.
References
1.
Taylor-WeinerH and Graff ZivinJ. (2015). Medicine's wild west—unlicensed stem-cell clinics in the United States. N Engl J Med, 373:985–987.
2.
Holman CM. (2017). FDA's efforts to tame the “wild west” of regenerative medicine. Biotechnol Law Rep, 5:217–221.
3.
KuriyanAE, AlbiniTA, TownsendJH, RodriguezM, PandyaHK, LeonardRE, 2nd., ParrottMB, RosenfeldPJ, Flynn JrHW. and GoldbergJL. (2017). Vision loss after intravitreal injection of autologous “Stem Cells” for AMD. N Engl J Med, 376:1047–1053.
4.
BourinP, BunnellBA, CasteillaL, DominiciM, KatzAJ, MarchKL, RedlH, RubinJP, YoshimuraK and GimbleJM. (2013). Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy, 15:641–648.
5.
DominiciM, Le BlancK, MuellerI, Slaper-CortenbachI, MariniF, KrauseD, DeansR, KeatingA, ProckopD and HorwitzE. (2006). Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy, 8:315–317.
6.
ZukPA, ZhuM, MizunoH, HuangJ, FutrellJW, KatzAJ, BenhaimP, LorenzHP and HedrickMH. (2001). Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng, 7:211–228.
7.
KurnickNB, MontanoA, GerdesJC and FederBH. (1958). Preliminary observations on the treatment of postirradiation hematopoietic depression in man by the infusion of stored autogenous bone marrow. Ann Intern Med, 49:973–986.
8.
BatemanME, StrongAL, GimbleJM and BunnellBA. (2018). Concise review: using fat to fight disease: a systematic review of nonhomologous adipose-derived stromal/stem cell therapies. Stem Cells, 36:1311–1328.
9.
ToyserkaniNM, JorgensenMG, TabatabaeifarS, JensenCH, SheikhSP and SorensenJA. (2017). Concise review: a safety assessment of adipose-derived cell therapy in clinical trials: a systematic review of reported adverse events. Stem Cells Transl Med, 6:1786–1794.
10.
MarksP and GottliebS. (2018). Balancing safety and innovation for cell-based regenerative medicine. N Engl J Med, 378:954–959.
11.
MarksPW, WittenCM and CaliffRM. (2017). Clarifying stem-cell therapy's benefits and risks. N Engl J Med, 376:1007–1009.
12.
Alvaro-GraciaJM, JoverJA, Garcia-VicunaR, CarrenoL, AlonsoA, MarsalS, BlancoF, Martinez-TaboadaVM, TaylorP, et al. (2017). Intravenous administration of expanded allogeneic adipose-derived mesenchymal stem cells in refractory rheumatoid arthritis (Cx611): results of a multicentre, dose escalation, randomised, single-blind, placebo-controlled phase Ib/IIa clinical trial. Ann Rheum Dis, 76:196–202.
13.
McIntoshKR, LopezMJ, BornemanJN, SpencerND, AndersonPA and GimbleJM. (2009). Immunogenicity of allogeneic adipose-derived stem cells in a rat spinal fusion model. Tissue Eng Part A, 15:2677–2686.
14.
KurtzbergJ, ProckopS, TeiraP, BittencourtH, LewisV, ChanKW, HornB, YuL, TalanoJA, et al. (2014). Allogeneic human mesenchymal stem cell therapy (remestemcel-L, Prochymal) as a rescue agent for severe refractory acute graft-versus-host disease in pediatric patients. Biol Blood Marrow Transplant, 20:229–235.
15.
PrasadVK, LucasKG, KleinerGI, TalanoJA, JacobsohnD, BroadwaterG, MonroyR and KurtzbergJ. (2011). Efficacy and safety of ex vivo cultured adult human mesenchymal stem cells (Prochymal) in pediatric patients with severe refractory acute graft-versus-host disease in a compassionate use study. Biol Blood Marrow Transplant, 17:534–541.