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Clinical trials (1)

Manifestation of Novel Social Challenges of the European Union in the Teaching Material of Medical Biotechnology Master’s P rogrammes at the University of Pécs and at the University of Debrecen Identification number : TÁMOP-4.1.2-08/1/A-2009-0011.

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Clinical trials (1)

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  1. Manifestation of Novel Social Challenges of the European Unionin the Teaching Material ofMedical Biotechnology Master’s Programmesat theUniversity of Pécs and at the University of Debrecen Identificationnumber: TÁMOP-4.1.2-08/1/A-2009-0011

  2. Manifestation of Novel Social Challenges of the European Unionin the Teaching Material ofMedical Biotechnology Master’s Programmesat theUniversity of Pécs and at the University of Debrecen Identification number: TÁMOP-4.1.2-08/1/A-2009-0011 Dr. Judit Pongrácz Threedimensionaltissuecultures and tissueengineering – Lecture 23 Clinicaltrials(1)

  3. Definition of a clinical trial • Health related research studies performed in human beings

  4. Types of clinical trials • Treatment trials • Prevention trials • Diagnostic trials • Screening trials • Quality of life trials

  5. Participants in a clinical trial • To gain access to novel research treatment • Provide information on drug efficacy and potential toxicity

  6. Benefits of taking part in a clinical trial • Gain access to novel therapies • Obtain expert medical care • Contribution to medical research

  7. Risks of clinical trials • Unpleasant or life-threatening side effects • The experimental treatment may not be effective

  8. Process of clinical trials • Based on research results • Based on a specific protocols • Participants are continuously monitored • Results assessed and statistics are performed

  9. Phases of clinical trials • Phase 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

  10. Stem cell therapy and clinical trials • Hematopoietic stem cell transplantation is the first stem cell based therapy strategy that has gone into clinical trials

  11. Stages to reach a marketable cell-based therapeutic product Research Animal tests Clinicaltrials Phase I, II, III, IV Marketable product Production Market research

  12. Manifestation of Novel Social Challenges of the European Unionin the Teaching Material ofMedical Biotechnology Master’s Programmesat theUniversity of Pécs and at the University of Debrecen Identification number: TÁMOP-4.1.2-08/1/A-2009-0011 Dr. Judit Pongrácz Threedimensionaltissuecultures and tissueengineering – Lecture 24 Clinicaltrials(2)

  13. Clinicaltrialsforcellulartherapy of liverfailure • Autologous BMSC – notreadyforroutineclinicaltherapy • Differentiated BMSC using HGF

  14. Liver dialysis • Ammonia causes encephalopathia • Extracorporeal detoxification • Dialysis-like solutions

  15. Bioartificialliver Oxygen Plasma filter Bioreactor PKM-19 Livercells Patient’s plasma

  16. ELAD®bioartificialliver Incubator ELADTM Heparin infusion Bloodpump ELADTM Ultrafiltrate pump Plasma filter Pumping system ELADTM ELADTM Oxygenator Cell filter Recirculation pump Bloodcircuit Ultrafiltratecircuit Glucose Reservoir Glucose infusionpump Priming infusion line

  17. Cell-free ELAD: MARS Bloodcircuit Mars-Albumincircuit Dialysatecircuit MarsFluxDialyzer diaMarsFlux Adsorptioncolumns diaFlux Dialyzer Blood pump Anion exchange resin Activated charcoal Albumin pump

  18. Skingrafting and replacement Burninjuries Chronicwounds, e.g. diabeticor PAD ulcers Cosmeticsurgery

  19. Structure of theskin Stratumcorneum Hair Stratumlucidum Sebaceous gland Erector pili muscle Stratumgranulosum Stratummucosum Epidermis Stratumgerminativum Dermis Sweat gland Artery Fat (Adiposetissue) Nerve

  20. Purpose of skingrafting Restorethebarrierfunction-keratinocytes Recently no nerve, vascular, sweatglansorhairfolliclescan be includedintotxskin

  21. Skingrafts • Fullthicknessburns - dermis and epidermisarebothlost • Partialthicknessburns - epidermis is largelyintact • If more, than 30-40% body surface is burnt • Smallersurfaceburnsmay be curedwithsplitthicknessautografts

  22. Autologousskingrafts Skin is meshedto covera largewound Grafttakenfrom patient’s healthyskin Wound

  23. CulturedEpithelialAllograft(CEA) I • CEA alone • Intagracombinedwith CEA

  24. CulturedEpithelialAllograft(CEA)II Transplantation of autologousculturedepidermis Patient Injuredarea Grafting Skinbiopsy Skin specimen Sheetformation Cellseeding/ Inoculation Culture Isolationof keratinocytes Feedercells

  25. Tissueengineeredskinmethodology Enzymaticsegregation Epidermis Dermis 9x P2 24hr Enzymaticremoval of 3T3s 9x Isolationof keratinocytes Feeder 3T3 fibroblasts P2 Proliferation and differentiation of multilayerepithelialsheets P0 Mediumchange 9x P0 P1 The epithelialsheetsareremovedforclinicaluse

  26. Tissueengineeredskinproductsavailableforclinicaluse

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