BIOengineered grafts for Cartilage Healing In Patients

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1 Nacionalni informativni dan za Zdravlje, demografske promjene i kvalitetu života (SC1), Obzor BIOengineered grafts for Cartilage Healing In Patients doc.dr.sc. ALAN IVKOVIĆ Zavod za ortopediju, KB Sveti Duh Medicinski fakultet, Sveučilište u Zagrebu Odjel za biotehnologiju, Sveučilište u Rijeci

2 PREGLED PREDAVANJA FP7 BIO-COMET PORUKE ZA DOMA HORIZON 2020 BIO-CHIP Q&A

3 IZVORI FINANCIRANJA The research leading to these results has received funding from the European Union's Seventh Framework Programme (FP7/ ) under grant agreement n Bioreactor based, clinically oriented manufacturing of engineered tissues (BIO-COMET) and Horizon 2020 under grant agreement n Bioengineered grafts for cartilage healing in patients (BIO-CHIP)

4 KAKO DOBITI EU PROJEKT?

5 POZOVITE KOLEGE NA CRES...PROJEKT JE VAŠ!

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9 INSTITUCIONALNA PODRŠKA?

10 UZagreb Medicinski fakultet Veterinarski fakultet KB Sveti Duh

11 BIOREACTOR-BASED, CLINICALLY ORIENTED MANUFACTURING OF ENGINEERED TISSUES (BIO-COMET) Collaborative Project SME-targeted small or medium scale focused research project Health : Tools, technologies and devices for application in regenerative medicine

12 BIO-COMET KONZORCIJ

13 AUTOLOGNA TRANSPLANTACIJA HONDROCITA The conventional graft manufacturing process AUTOMATIC PERFUSION BIOREACTOR SYSTEM

14 OPTIMIZIRANI PROCES UZORAK HRSKAVICE DIGESTIJSKA JEDINICA PERFUZIJSKI BIOREAKTOR ZRELI OSTEOHONDRALNI PRESADAK

15 MODEL OVCE

16 FINANCIJSKI ASPEKT 6M Eur

17 NOVA TEHNOLOGIJA Cocoon by Octane

18 NOVA RADNA MJESTA

19 PORUKE ZA DOMA

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21 PORUKE ZA DOMA NETWORKING, NETWORKING, NETWORKING

22 PORUKE ZA DOMA BUDITE INTER- I TRANSDISCIPLINARNI

23 PORUKE ZA DOMA IAKO ADMINISTRACIJA NIJE (tako veliki) BAUK OZBILJNO JE SHVATITE...

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25 SUCCESS 3% HEALTH FAILURE 97% APLIKACIJA

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28 BIO-CHIP KONZORCIJ

29 BIOengineered grafts for Cartilage Healing In Patients BIOCHIP will carry out a multicenter, prospective phase II clinical trial to treat knee cartilage injuries using engineered grafts based on autologous nasal chondrocytes (NC). Importantly, molecular/mechanical characterization, large size animal studies and a phase I trial carried out by BIOCHIP partners have already shown the compatibility of NC upon implantation in a joint, with promising preliminary clinical results.

30 SPECIFIČNI CILJEVI SAMOG PROJEKTA (1) To test the hypothesis that the maturation of NCbased cartilage grafts improves the clinical efficacy in the treatment of cartilage lesions (108 patients will be recruited to reach statistical significance) (2) To extend the range of clinical indications of NCbased grafts to so far untreatable pre-osteoarthritic lesions ( kissing cartilage lesions in a sheep model)

31 nose2knee klinička studija

32 UZGOJ TKIVA IN VITRO ZA POTREBE ANIMALNE STUDIJE

33 MODEL OVCE Patellofemoral joint Non-kissing lesion Patella Kissing lesion Trochlea femoris Treatment group 1: NC-TECI Patella Treatment group 2: NC-MACI Patella Control: Empty defect Patella Trochlea femoris Trochlea femoris Trochlea femoris Alterirajuca kissing lezija / lateralno, medijalno

34 OSTEOHONDRALNI DEFEKT

35 VLASTITI PROTOKOL ESKPLATACIJE 1. PHOTODOCUMENTATION - Standardized - Same camera - Same photographer - 6 photos/defect ICRS MACROSCOPIC SCORE - Independant evaluators 2. OBTAINING OSTEOCHONDRAL TISSUE SAMPLES - ½ in the fixative - ½ freezed

36 ANALIZA EKSPLANTATA (imaging) µct 7T

37 ANALIZA EKSPLANTATA (morfologija) HISTOLOGY: HE, SAFRANIN O, PICROSIRIUS (ICRS II) IHC: COLLAGEN I and II, AGRECCAN IF: COLLAGEN I and II BIOCHEMISTRY: COLLAGEN I and II, GAG, WATER

38 ANALIZA EKSPLANTATA (morfologija)

39 INTER- I TRANSDISCIPLINANOST Vezane treće strane MEDICINSKI FAKULTET (beneficiary) VETERINARSKI FAKULTET KLINIČKA BOLNICA SVETI DUH PRIRODOSLOVNO- MATEMATIČKI FAKULTET

40 INSTITUCIONALNA PODRŠKA DEKAN PRODEKAN ZA MEĐUNARODNE ODNOSE URED ZA ZNANOST I TRANSFER TEHNOLOGIJE PRAVNA SLUŽBA, RAČUNOVODSTVO... AGENCIJA ZA MOBILNOST I PR. EU

41 PRAVNA REGULATIVA 1. GRANT AGREEMENT 2. CONSORTIUM AGREEMENT 3. SPORAZUM O PARTNERSTVU NA PROJEKTU BIO-CHIP

42 PISANJE PROJEKTNE PRIJAVE (PROPOSAL) VRIJEME RELEVANTNOST ZA CALL PAŽLJIVO PLANIRANJE (work packages, deliverables, milestones)

43 PISANJE PROJEKTNE PRIJAVE (BUDGET)

44 PISANJE PROJEKTNE PRIJAVE (MAN/MONTHS)

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46 Team work makes the dream work (John C. Maxwell)

47 SURADNJA Planiranje i pisanje projektne prijave Planiranje i provođenje kliničkog pokusa Planiranje pretkliničkih istraživanja na velikim modelima (ovca) Detaljna morfološka analiza (histologija, IHC, biokemija, molekularna dijagnostika) Napredne slikovne metode (µct i MR) Management projekta

48 HVALA NA POZORNOSTI

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