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Manifestation of Novel Social Challenges of the European Union in the Teaching Material of Medical Biotechnology Master’s Programmes at the University of Pécs and at the University of Debrecen

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(1)

Medical Biotechnology Master’s Programmes

at the University of Pécs and at the University of Debrecen

Identification number: TÁMOP-4.1.2-08/1/A-2009-0011

(2)

CLINICAL TRIALS (1)

Dr. Judit Pongrácz

Three dimensional tissue cultures and tissue engineering – Lecture 23

Medical Biotechnology Master’s Programmes

at the University of Pécs and at the University of Debrecen

Identification number: TÁMOP-4.1.2-08/1/A-2009-0011

(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

Market research Marketable

product

Clinical trials

Production

Phase I, II, III, IV

(12)

CLINICAL TRIALS (2)

Dr. Judit Pongrácz

Three dimensional tissue cultures and tissue engineering – Lecture 24

Medical Biotechnology Master’s Programmes

at the University of Pécs and at the University of Debrecen

Identification number: TÁMOP-4.1.2-08/1/A-2009-0011

(13)

Clinical trials for cellular therapy of liver failure

• Autologous BMSC – not ready for routine clinical therapy

• Differentiated BMSC using HGF

(14)

Liver dialysis

• Ammonia causes encephalopathia

• Extracorporeal detoxification

• Dialysis-like solutions

(15)

Bioartificial liver

Patient’s plasma

Oxygen

PKM-19 Liver cells Plasma

filter

Bioreactor

(16)

ELAD

®

bioartificial liver

Blood circuit

Ultrafiltrate circuit Glucose

ELADTM

ELADTM ELADTM ELADTM

Plasma filter

Oxygenator

Pumping system

Reservoir

Blood pump

Ultrafiltrate pump

Recirculation pump

Glucose infusion pump Priming

infusion line

Heparin infusion

Incubator

Cell filter

(17)

Cell-free ELAD: MARS

MarsFlux Dialyzer diaMarsFlux Adsorption columns

diaFlux Dialyzer Blood circuit Mars-Albumin circuit Dialysate circuit

Blood pump

Albumin pump Activated

charcoal Anion

exchange resin

(18)

Skin grafting and replacement

• Burn injuries

• Chronic wounds, e.g. diabetic or PAD ulcers

• Cosmetic surgery

(19)

Structure of the skin

Artery

Nerve

(Adipose tissue) Epidermis

Dermis

Fat

Sweat gland

Erector pili muscle Hair

Sebaceous gland Stratum corneum

Stratum lucidum

Stratum mucosum Stratum granulosum

Stratum germinativum

(20)

Purpose of skin grafting

• Restore the barrier function-keratinocytes

• Recently no nerve, vascular, sweat glans or hair follicles can be included into tx skin

(21)

Skin grafts

• Full thickness burns - dermis and epidermis are both lost

• Partial thickness burns - epidermis is largely intact

• If more, than 30-40% body surface is burnt

• Smaller surface burns may be cured with split thickness autografts

(22)

Autologous skin grafts

Skin is meshed to cover a large wound

Graft taken from patient’s healthy skin

Wound

(23)

Cultured Epithelial Allograft (CEA) I

• CEA alone

• Intagra combined with CEA

(24)

Cultured Epithelial Allograft (CEA) II

Transplantation of autologous cultured epidermis

Patient

Injured area Skin biopsy

Skin specimen

Isolation of keratinocytes

Feeder cells Cell seeding/

Inoculation Culture

Sheet formation

Grafting

(25)

Tissue engineered skin methodology

The epithelial sheets are removed for clinical use 9x

9x

Enzymatic removal of 3T3s

Proliferation and

differentiation of multilayer epithelial sheets

9x

P2

P2

Medium change

P0

P0

P1 Dermis

Epidermis

Isolation of keratinocytes

Feeder 3T3 fibroblasts Enzymatic

segregation

24hr

(26)

Tissue engineered skin products available for clinical use

Type Products

Epidermal cover

• CEpicell (Genzyme) –cultured epitermal sheets

• Epidex (Modex Therapeutics)- epidermal sheets from hair biopsies

• Myskin (CellTran)- cells in a synthetic carrier

• C3- cells in a spray

• Cultured allogenic keratinocytes

• Cultured autologous keratinocytes

Dermal replacement

• Integra (Integra)

• Alloderm (Lifecell)

• Permacol (Tissue Science Labs)

• Dermagraft (Advaced BioHealing)

• Transcyte (Advanced BioHealing) Epidermal/dermal

replacement

• Permaderm (Cambrex)

• Apligraf (Novartis)

• Orcel (Ortec International)

Hivatkozások

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