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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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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

commercial products 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

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

Dr. Judit Pongrácz

Threedimensionaltissuecultures and tissueengineering – Lecture 21

Commercialproducts(1)
organ failure
Organfailure
  • Organ failure is organ dysfunction to such a degree that normalhomeostasiscannot be maintained without external clinical intervention.
  • Recently, a curativetherapyfororganfailures is onlyorgantransplantation
  • Regenerativemedicineoffersthesolutiontoavoidgraftrejection, the most commoncomplication of transplantation
regenerative medicine
Regenerativemedicine
  • Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects.
  • Ithas the potentialtosolvetheproblemsof:
  • the shortage of organs available for donation compared to the number of patients that require life-saving organ transplantation
  • organtransplantrejection, since the organ's cells will match that of the patient
commercialization of tissue engineering
Commercialization of tissueengineering
  • Rapid development of tissue engineering allows the commercialization of several products
  • Cellular therapies offer therapeutic solutions for serious diseases like organ failure
  • More and more products are approved for regular clinical use
cardiovascular diseases
Cardiovasculardiseases

Heartvalves

Pulmonaryvalve

Aorticvalve

Leftcoronary

artery

Right coronary

artery

Tricuspidvalve

Bicuspidvalve

artificial heart valves
Artificial heart valves
  • Mechanical heart valves are made of biocompatible metal alloys and plastics
  • Durable structure, may last for many years
  • The non-biological surface of implants may cause blood clotting disturbances
  • Bacterial infection is a serious risk
biological heart valves
Biological heart valves
  • Valves of animals, like pigs, which undergo a decellularization procedure in order to make them suitable for implantation in the human heart.
  • Other types of biological valves (made from decellularized equine or bovine pericardium) are sewn to a frame
  • They are less durable than mechanical valves
tissue engineered heart valves
Tissue engineered heart valves
  • Scaffolds seeded with endothelial cells
  • Perspective:
    • Enhanced durability
    • No clotting disorders
    • No increased infection risk
    • Similar mechanical properties to that of native valves
    • BMMC seeded TE heart valves are available but only for the pulmonary circulation (right heart side)
replacement of blood vessels
Replacement of blood vessels
  • Arterial „organ failure” occurs mainly as a result of atherosclerosis
  • Venous „organ failure” occurs most frequently in venous varicosity
  • Replacement of damaged organs: only arteries
  • Autografts, xenografts, artificial stents or blood vessels
vascular tissue engineering
Vascular tissue engineering
  • Xenografts: decellularized veins, ureters or intestinal submucosa from animals (canine, porcine, rabbit origin mainly)
  • Recently, human allografts are used also
  • PCLA-PGA copolymer heart valve constructs seeded with BMSC in paediatric patients
developments in vascular te
Developments in vascular TE
  • Tissue printing of a blood vessel:
  • Cells: mixture of smooth muscle and endothelium
  • Spontaneous structure will form
vascular grafts
Vascular grafts
  • Vascular grafting in surgery uses mainly autografts: the patient’s own veins or arteries are used to bridge closures on blood vessels.
  • Example: CABG surgery
  • Vascular stenting: Percutaneous Coronary Intervention (PCI), Abdominal Aortic Aneurysm treatment
  • Artificial blood vessel: Aortofemoral bypass
vascular tissue engineering1
Vascular tissue engineering
  • Xenografts: decellularized veins, ureters or intestinal submucosa from animals (canine, porcine, rabbit origin mainly)
  • Recently, human allografts are used also
  • PCLA-PGA copolymer heart valve constructs seeded with BMSC in paediatric patients
tissue engineered blood vessel
Tissue engineered blood vessel
  • TE bloodvesselsareusedonlyinlowpressurepulmonarycirculation
  • Thesegraftsarenotdurableenoughtowithstandhigharterialpressure

Cellisolation

Cellexpansion

Small-vein

harvest

Cellseeding

onpolymer

Tissue-engineeredgraft

tebv production
TEBV production
  • HUVEC and SMC were grown in conventional tissue culture flasks to form a monolayer which could be peeled off
  • Monolayers were wrapped around inert tubular supports to form concentric layers
  • Inner membrane: dehydrated fibroblast sheet
  • Smooth muscle cells formed the second sheet
  • Fibroblast sheet was rolled on to form an adventitia
  • Endothelial cells were seeded on the inner surface
cartilage injury and regeneration
Cartilage injury and regeneration
  • Cartilage injury: acute or chronic
  • Acute injury: mainly traumatic
  • Chronic injury: inflammation/degeneration
  • Arthritis/Arthrosis
  • Regeneration is slow and in case of massive damage or chronic disease, degeneration occurs
  • Heavily effects life quality and frequently occurs in the developed world
challenges for cartilage te
Challenges for cartilage TE

Hyalinous cartilage, not fibrous cartilage needed

Avascular tissue, chondrocytes have low metabolic rate

Mechanical stimulation of engineered construct is necessary for good results

autologous chondrocyte implantation aci i
Autologouschondrocyteimplantation(ACI) I

200-300 mg cartilage is harvested by arthroscopically from a less weight bearing area (intercondylar notch superior ridge of the medial or lateral femoral condyle)

The matrix is digested enzymatically,chondrocytes are isolated

Chondrocytes are cultured in vitro for approximately four to six weeks

autologous chondrocyte implantation aci ii
Autologouschondrocyteimplantation(ACI) II
  • Cultured chondrocytes are applied on the damaged area during an open-knee surgery (also called arthrotomy). These autologous cells should adapt themselves to their new environment by forming new cartilage.
  • During the implantation, chondrocytes are applied on the damaged area in combination with a membrane (tibialperiosteum or biomembrane) or pre-seeded in a scaffold matrix.
autologous chondrocyte implantation aci iii
Autologouschondrocyteimplantation(ACI)III

Tissuecultureof

isolatedchondrocytes

Biopsyof

healthycartilage

Culturedchondrocytes

injectedunder patch

Damagedcartilage

(Lesion)

Periosteal patch

harvestedfromtibia

commercial products for aci
Commercialproductsfor ACI

Carticel® service: Genzyme

Harvestedcartilage is senttoGenzyme

Release of chondrocytes, culturing and proliferation of chondrocytesareperformedbythefirm

The surgeonreceivestheready-to-implantdifferentiatedcells

matrix induced aci maci
Matrix-induced ACI (MACI)
  • Harvested chondrocytes are expanded on hyalin or collagen matrices
  • No significant difference in the clinical outcome between ACI and MACI
  • Use of MSCs in MACI are in trial currently
  • Main challenge: differentiation towards hyalin cartilage instead of fibrous cartilage
  • Many different matrices are used
commercial products 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 22

Commercialproducts(2)
bioartificial liver assist device
Bioartificial liver Assist Device
  • Liver has remarkable regeneration capacity on its own
  • Liver replacement treatments are applied in both acute and chronic liver failure
  • Bridges the time until a suitable donor is found
  • Support until the transplanted liver starts working
  • Treatment option for acute-on-chronic liver failure
  • Treatment in acute liver failure: replacing liver detoxification function until the patient’s own liver regenerated on its own
liver dialysis
Liver dialysis
  • Dialysis-like solutions
  • No living cells used
  • Ammonia causes encephalopathia
  • Extracorporeal detoxification
bioartificial liver
Bioartificialliver

Oxygen

Plasma

filter

Bioreactor

PKM-19 Livercells

Patient’s

plasma

elad bioartificial liver
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

cell free elad mars
Cell-free ELAD: MARS

Bloodcircuit

Mars-Albumincircuit

Dialysatecircuit

MarsFluxDialyzer

diaMarsFlux

Adsorptioncolumns

diaFlux

Dialyzer

Blood

pump

Anion

exchange

resin

Activated

charcoal

Albumin

pump

skin grafting and replacement
Skin grafting and replacement
  • Burn injuries
  • Chronic wounds, e.g. diabetic or PAD ulcers
  • Cosmetic surgery
structure of the skin

Hair

Erector pili muscle

Sebaceous gland

Epidermis

Dermis

Sweat gland

Fat

Structure of theskin
purpose of skin grafting
Purpose of skingrafting
  • Restorethebarrierfunction→keratinocytes
  • Recently no nerve, vascular, sweatglandsorhairfolliclescan be includedintotheskin
split thickness grafts
Split-thicknessgrafts
  • 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, TE products are welcome by surgeons
  • Smaller surface burns may be cured with split thickness autografts
autologous skin grafts
Autologousskingrafts

Skin is meshedto

covera largewound

Grafttakenfrom

patient’s

healthyskin

Wound

integra skin replacement
Integra®skinreplacement

1. A patch of syntheticskin is placedon top of damagedtissue

2. The patch containschemicalsthattriggergrowth of newbloodvessels and proteinsforskinregeneration

3. The bloodvesselsrestartblood flow tothearea and thesiliconemembrane is removed

Undamageddermis

Undamagedepidermis

Siliconemembrane

Bloodvesselsforming

Restartedblood flow

Underlyingtissue

Syntheticskinpatch withsiliconemembrane

7 daysafterapplication

14+ daysafterapplication

4. A smallgraft of thepatient’sownskinreplacesthesiliconemembrane

5. The skingrafteventuallycreates a smoothsurface of regeneratedskin

Meshedskingraft

Regeneratedskin

14+ daysafterapplication

35+ daysafterapplication

cultured epithelial allograft cea
CulturedEpithelialAllograft(CEA)
  • CEA alone
  • Integracombinedwith CEA