GENReports: Market & Tech Analysis

Transcription

1 GENReports: Market & Tech Analysis > Enal Razvi, Ph.D. Managing Director Select Biosciences, Inc.

2 There! is! much! interest! of! late! in! the! deployment! of! adipose! Assue! and!adiposebderived!stem!cells!for!regeneraave!medicine! The!use!of!adipose!Assue!in!cosmeAc!and!reconstrucAve!surgery!is! well!documented!and!now!there!is!a!collision!taking!place!between! clinicians!who!are!focusing!on!adipose!assue!and!clinicianbscienasts! who! are! seeking! to! understand! the! acave! moieaes! within! the! adipose! Assue namely! the! adiposebderived! stem! cells! as! well! as! other!components!of!this!milieu!which!mediate!regeneraaon! In!this!GEN!report!we!explore!this!expanding!space!based!on!Select! Biosciences! Clinical! TranslaAon! of! Stem! Cells! 2014! Conference! [excerpang!key!presentaaons],!which!brought!together!clinicians!as! well! as! researchers! exploring! and! ualizing! autologous! adipose! AssueBderived! cells! (the! stromal! vascular! fracaon,! SVF)! for! regeneraave!medicine! Scope,of,this,Report! Adipose,Tissue,is,Gaining,Acceptance,as,a,Potent,Source,of, Stem,Cells,for,RegeneraDve,Medicine,

3 The,Stakeholders,in,Adipose,Tissue,and,Stem,Cells,for,RegeneraDve, Medicine,Came,Together,at,the,Select,Biosciences,Clinical,TranslaDon,of, Stem,Cells,2014,Conference! Select,Biosciences,Conference,Brought,Together,all,the,Stakeholders,in,this,Broad,Space,Composed,of, Clinical,TranslaDon,of,Stem,Cells,,! Focus!on!Adipose!Tissue!as!a!Means!for!MediaAng!RegeneraAve!Medicine!! Blend!of!Clinicians,!Surgeons,!ClinicianBScienAsts,!and!Researchers!! Current!Progress!and!Challenges!in!the!Clinical!Deployment!of!Stem!Cells!! Stem!Cells!for!Dermatological,!Orthopedic,!and!Dental!ApplicaAons!"!Illustrated!by!PresentaAons!from! Clinicians!from!Around!the!World!! Clinical!PracAcum!"!Presents!HandsBOn!and!in!RealBTime!the!IsolaAon!and!Processing!of!Adipose!Tissue!to! Harvest!Stem!Cells!! John!Sterling,!EditorBinBChief!of!GEN!Hosted!a!Panel!Discussion!Focusing!on!the!Big!Picture!of!RegeneraAve! Medicine!

4 Fat Processing & Storage Overview Source:!!Mel!Bircoll,!MD!

5 Storing Autologous Fat and Utilizing It Clinically Harvest fat Excess fat placed in supplied collection bag and shipping box Mailed FedEx priority overnight Fat processed same day in FDA registered facility Tested for cell viability and sterility* Fat stored in physician s selected configuration for future procedures Requested fat sample removed from storage Fat sample thawed Sample delivered next day for injection. # Viability!tested!uAlizing!propidium!iodide!(PI)!and!Nexcelom!Vision!Cell!Counter!! # 14!day!viability!and!growth!analysis!performed!uAlizing!ceiling!culture!method! # FDA!mandated!14!day!sterility!test!uAlizing!the!Bac/T!Alert!system!for!anaerobic!and!aerobic! growth! Adapted!from:!!Mel!Bircoll,!MD!

6 Fat Collection Picture,courtesy,of,Dr.,Fredric,Stern,

7 Fat Aliquoting for Transfer Picture,courtesy,of,Dr.,Fredric,Stern,

8 The Potential of Fat for Regenerative Medicine Adipose Tissue (Fat) is easily accessible and a significant source of Regenerative Cells which can be processed into multiple cell based products or stored for future use. Adipose Tissue (AT) - Create master cell sample - Storage or processing to SVF or ADSCs for Regenerative Medicine - Cosmetic fat grafting Stromal Vascular Fraction (SVF) - Direct use in orthopedic and other treatments - Cryo-storage or further processing to ADSCs Adipose Derived Stem Cells (ADSCs) - Direct use for infusion and other regenerative cellular therapies - Confirmed self-renewal and differentiation capacity - Storage or additional expansion and differentiation to other cell types Adapted!from:!!Mel!Bircoll,!MD!

9 Growing,PublicaDons,in,Stromal,Vascular, FracDon,(SVF)!the,Harbinger,of,Stem,Cells! Number,of,PublicaDons,,indexed,in,PubMed,(MEDLINE),database,for,query, stromal,vascular,fracdon,(svf).,, Source:,GoPubMed,

10 In Conclusion There, is, growing, clinical, and, sciendfic, evidence, of, the, potendal,of,adipose,dssue,for,regeneradve,medicine, The,field,is,translaDng,from,the,mere,use,of,fat,for,cosmeDc, purposes,by,plasdc,surgeons,to,the,possible,udlizadon,of,fat, for,regeneradve,purposes, The,mechanism,of,acDon,of,fat,[and,the,stem,cells,derived, thereof], remain, unclear, at, present,, however, the, clinical, results,to,date,cannot,be,ignored,and,warrant,more,work,to, understand, the, acdve, biological, factors, [cells,, cytokines,, extracellular,vesicles,,or,a,combinadon,thereof], The, sciendfic, and, clinical, potendal, of, autologous, adipose, Dssue, therefore, must, be, validated, and, we, condnue, to, follow, this, space, in, our, condnuing, industry, tracking, of, the, various, segments, of, the, cellular, therapy/regeneradve, medicine,marketplace,