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Manifestation of Novel Social Challenges of the European Unionin the Teaching Material ofMedical Biotechnology Masters Programmesat the University of Pcs and at the University of DebrecenIdentification number: TMOP-4.1.2-08/1/A-2009-0011Clinical trials (1)Dr. Judit PongrczThree dimensional tissue cultures and tissue engineering Lecture 23Manifestation of Novel Social Challenges of the European Unionin the Teaching Material ofMedical Biotechnology Masters Programmesat the University of Pcs and at the University of DebrecenIdentification number: TMOP-4.1.2-08/1/A-2009-0011Definition of a clinical trialHealth related research studies performed in human beingsTMOP-4.1.2-08/1/A-2009-0011Types of clinical trialsTreatment trialsPrevention trialsDiagnostic trialsScreening trialsQuality of life trialsTMOP-4.1.2-08/1/A-2009-0011Participants in a clinical trialTo gain access to novel research treatmentProvide information on drug efficacy and potential toxicityTMOP-4.1.2-08/1/A-2009-0011Benefits of taking part in a clinical trialGain access to novel therapiesObtain expert medical careContribution to medical researchTMOP-4.1.2-08/1/A-2009-0011Risks of clinical trialsUnpleasant or life-threatening side effectsThe experimental treatment may not be effectiveTMOP-4.1.2-08/1/A-2009-0011Process of clinical trialsBased on research resultsBased on a specific protocolsParticipants are continuously monitoredResults assessed and statistics are performed

TMOP-4.1.2-08/1/A-2009-0011Phases of clinical trialsPhase I small group of people (20-80)Phase II larger group of people (100-300)Phase III large group of people (1000-3000)Phase IV marketing studies

TMOP-4.1.2-08/1/A-2009-0011Stem cell therapy and clinical trialsHematopoietic stem cell transplantation is the first stem cell based therapy strategy that has gone into clinical trials

TMOP-4.1.2-08/1/A-2009-0011Stages to reach a marketable cell-based therapeutic productResearchAnimal testsMarket researchMarketable productClinical trials

ProductionPhase I, II, III, IVTMOP-4.1.2-08/1/A-2009-0011Clinical trials (2)Dr. Judit PongrczThree dimensional tissue cultures and tissue engineering Lecture 24Manifestation of Novel Social Challenges of the European Unionin the Teaching Material ofMedical Biotechnology Masters Programmesat the University of Pcs and at the University of DebrecenIdentification number: TMOP-4.1.2-08/1/A-2009-0011Clinical trials for cellular therapy of liver failureAutologous BMSC not ready for routine clinical therapyDifferentiated BMSC using HGF

TMOP-4.1.2-08/1/A-2009-0011Liver dialysisAmmonia causes encephalopathiaExtracorporeal detoxificationDialysis-like solutions

TMOP-4.1.2-08/1/A-2009-0011Bioartificial liverPatientsplasmaOxygenPKM-19 Liver cellsPlasmafilterBioreactorTMOP-4.1.2-08/1/A-2009-0011ELAD bioartificial liver Blood circuitUltrafiltrate circuitGlucoseELADTMELADTMELADTMELADTMPlasma filterOxygenatorPumpingsystemReservoirBlood pumpUltrafiltratepumpRecirculationpumpGlucoseinfusion pumpPriminginfusion lineHeparininfusionIncubatorCell filterTMOP-4.1.2-08/1/A-2009-0011Cell-free ELAD: MARSMarsFlux DialyzerdiaMarsFluxAdsorption columnsdiaFluxDialyzerBlood circuitMars-Albumin circuitDialysate circuitBloodpumpAlbuminpumpActivatedcharcoalAnionexchangeresinTMOP-4.1.2-08/1/A-2009-0011Skin grafting and replacementBurn injuriesChronic wounds, e.g. diabetic or PAD ulcersCosmetic surgeryTMOP-4.1.2-08/1/A-2009-0011Structure of the skinArteryNerve(Adipose tissue)EpidermisDermisFatSweat glandErector pili muscleHairSebaceous glandStratum corneumStratum lucidumStratum mucosumStratum granulosumStratum germinativumTMOP-4.1.2-08/1/A-2009-0011Image copyrights expired, free to use19Purpose of skin graftingRestore the barrier function-keratinocytesRecently no nerve, vascular, sweat glans or hair follicles can be included into tx skin

TMOP-4.1.2-08/1/A-2009-0011Skin graftsFull thickness burns - dermis and epidermis are both lostPartial thickness burns - epidermis is largely intactIf more, than 30-40% body surface is burntSmaller surface burns may be cured with split thickness autografts

TMOP-4.1.2-08/1/A-2009-0011Autologous skin graftsSkin is meshed to cover a large woundGraft taken frompatientshealthy skinWoundTMOP-4.1.2-08/1/A-2009-0011Cultured Epithelial Allograft (CEA) ICEA aloneIntagra combined with CEA

TMOP-4.1.2-08/1/A-2009-0011Cultured Epithelial Allograft (CEA) IITransplantation of autologous cultured epidermisPatientInjured areaSkin biopsySkin specimenIsolation ofkeratinocytesFeeder cellsCell seeding/InoculationCultureSheet formationGraftingTMOP-4.1.2-08/1/A-2009-001124Tissue engineered skin methodologyThe epithelial sheets are removed for clinical use9x9xEnzymatic removal of 3T3sProliferation and differentiation of multilayer epithelial sheets9xP2P2Medium changeP0P0P1DermisEpidermisIsolation ofkeratinocytesFeeder 3T3 fibroblastsEnzymatic segregation24hrTMOP-4.1.2-08/1/A-2009-001125Tissue engineered skin products available for clinical useTypeProductsEpidermal coverCEpicell (Genzyme) cultured epitermal sheetsEpidex (Modex Therapeutics)- epidermal sheets from hair biopsiesMyskin (CellTran)- cells in a synthetic carrierC3- cells in a sprayCultured allogenic keratinocytesCultured autologous keratinocytesDermal replacementIntegra (Integra)Alloderm (Lifecell)Permacol (Tissue Science Labs)Dermagraft (Advaced BioHealing)Transcyte (Advanced BioHealing)Epidermal/dermal replacementPermaderm (Cambrex)Apligraf (Novartis)Orcel (Ortec International)TMOP-4.1.2-08/1/A-2009-0011