Presentation on theme: "Stem cells and materials technologies"— Presentation transcript:
1Stem cells and materials technologies Group 16 - Biomaterials and waste treatmentCiência 2009, 29-30th July 2009, Lisbon
2Strategic IntentTo target clinical needs through the integration of advanced adult stem cell biology and novel biomaterials into innovative therapeutic products for tissue regeneration
3History Academic spin-off of the 3B’s Research Group Created in November, 2007Installed since September 2008 at the European Institute of Excellence for Tissue Engineering and Regenerative Medicine Research, Guimarães, Portugal.Equipped with a future cGMP compliant facility for the processing of human tissue and cells (2003/94/EC Directive):300 m2 of clean room (classes B, C and D);250 m2 of R&D and QC laboratories.1st funding round estimated to be finished by Sept, 2009Start of operations estimated by Oct, 2009
4TeamCSO: Rui L. Reis, CEng., MSc., PhD. (n. 1968) – Founder, President and Chief Scientific Officer: is an Associated Professor at the Department of Polymer Engineering and Director 3B’s Research Group. Editor in Chief of the Journal of Tissue Engineering and Regenerative Medicine, John Wiley and Sons Inc. He is author or co-author of more than 900 scientific publications.CEO: Rui A. Sousa, CEng., MBA., PhD. (n. 1974) – Chief Executive Officer: is a senior researcher at the 3B’s Research Group. Possesses business experience in several industrial and consultancy domains. He is author or co- author of more than 90 scientific publications and communications.Dulce CostaLuísa PereiraJoão OliveiraAdrian Popa
5Social ContextThe WHO estimates that more than 600 million people are aged above 60, being estimated that this number reaches the 2 billion by 2050.Growing impact of degenerative or traumatic conditions due to demographic evolution, more dynamic lifestyles, and increased physical activities.
6Regenerative Medicine Overall MarketRegenerative Medicine2135Adaptado de Julian H S George et al4
7Use of stem cells from adipose tissue More than 1.6 billion people are overweight, of which 400 million are considered obese, with treatment costs between 2 and 8% of total health costs.Steep increase in aesthetical surgical procedures, being Europe responsible for about one third of this global market.
8Business Portfolio Stemmatters Therapeutics Stemmatters Life Banking Stemmatters Biomedical
10The Market for Cartilage Regeneration Current MarketsThe Market for Cartilage RegenerationPrevalence of articular cartilage related lesions in EuropeNearly traumatic incidents occur;About 7 million cases of treatable arthrosis occur each year.High market potential for cartilage regenerationAmong the biggest markets for connective tissues, being estimated between 1 to 5 billion €/year in Europe alone.Very high penetration of traditional treatment approachesArthroscopic lavage and debridement, microfracture and mosaicplasty rule the treatment of cartilage lesions.Cell based therapies with reasonable track record in this areaACT and MACI procedures are considered market references.
11Products Under Development Product PipelineProducts Under DevelopmentTypes of products currently under development:ATMPs (Advanced Therapy Medicinal Products)G01AT110C | pre-clinical | RECART Hydrogel/Adipose derived adult stem cellsG01AT300A | research | Hydrogel/Vascular stromal fraction derived cellsMDs (Medical Devices)G01MD210B | research | Injectable filler for soft tissue applicationsG01MD250B | research | Injectable filler system for maxillofacial applications
12Product PipelineStemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cellsCombined advanced therapy medicinal product (1394/2007 Regulation, CBMP EMEA guideline)Polysaccharide hydrogel as an active implantable deviceExopolysaccharide produced by microbial fermentation:Straight chain of repeating glucose, rhamnose and glucuronic acid units;Potential injectable system for minimally invasive surgeries;Processing under physiogical conditions without any reagents;Used in vivo for human ophthalmic applications and oral veterinary drug delivery.Adipose derived adult stem cellsIsolated from harvested adipose tissue:Dedicated or non-dedicated harvest procedure;Subpopulation isolated from the stromal vascular fraction;Good cell yield avoids previous cell expansion.
13Product PipelineStemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cellsNovel hydrogel system for TE applicationsJ.T. Oliveira et al, Patent Application
14Product PipelineStemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cellsGood performance upon subcutaneous implantation1 WEEK2 WEEKS3 WEEKSNo clear macroscopic change after 3 weeks of implantation.Extremely good integration with the surrounding tissues with a residual and thin fibrotic capsule.
15Product PipelineStemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cells8 WEEKSHuman chondrocytes form hyaline-like cartilage in vitroCol1 was not detected after 8 weeksCol2 increased ≈ 400 fold from 2-8 weeksAggrecan increased ≈ 35 fold from 2-8 weeksSox9 decreased close to zero from 2-8 weekshouse-keeping gene: GAPDH
16Product PipelineStemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cellsADIPOSE TISSUE FROM THE INTRASCAPULAR REGIONARTICULAR CARTILAGE FROM THE JOINTSCHONDROGENIC PRE ≠ MEDIUM WITH TGF-Β1 + BMP-2BASIC MEDIUM WITH NO PRE ≠PROLIFERATION INDUCING MEDIUM WITH FGF-2
17full-thickness defect Product PipelineStemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cellsImplantation siteRabbit articular cartilageArticular cartilagefull-thickness defectSubchondral drill(Ø 1 mm)(4 mm x 2-3 mm thickness)Study groupsA. Gellan + adipose tissue derived cells with pre differentiation period (ASC + GF*)B. Gellan + adipose tissue derived cells with no pre differentiation period (ASC)C. Gellan + articular chondrocytes (AC)D. Gellan alone (GELLAN)E. Empty defect (EMPTY)+++*TGF-Β1 + BMP-2Autologous approachTotal implantation time: 8 weeks[Cells]=10x106 cells/mlCharacterizationMacroscopic observationHistology (H&E for cell morphology and tissue formation and alcian blue for cartilage ECM formation)Histological scoring (Pineda score)Real-time PCR analysis (Sox9, Collagen type I, Collagen type II, and Aggrecan)J.T. Oliveira et al,Patent Application
18Product PipelineStemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cells0 weeks4 weeks8 weeksCombination of hydrogel with ASCs is able to regenerate focal cartilage lesionsJ.T. Oliveira et al, Patent ApplicationPatent Application/Priority date:
20Product PipelineStemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cellsAdvantages of the cartilage repair strategy include:Potential therapeutic performanceMinimally invasive system to be administered arthroscopicallyAvoids the need for a cartilage biopsyShorter time to therapy (TTT)Competitive cost as compared to traditional ACT and MACI procedures
26Main application markets for stem cells Current MarketsMain application markets for stem cellsCurrent uses of stem cells are made in 3 distinct medical related markets:Cell banking;Therapeutic development;Cell therapies.(source: Frost & Sullivan).
27Stemmatters Life Banking | Stem cell isolation and storage services Current OfferingStemmatters Life Banking | Stem cell isolation and storage servicesBone marrow (onstem service – B2C);Adipose tissue (adstem service – B2C):The treatment of tissues and biological residues generated in surgical procedures assures a cell banking opportunity not yet addressed.Market potential for the isolation and storage of adipose derived adult stem cells for autologous application is estimated to worth:75 million €/year for Spain, France, Germany, UK, Italy and Portugal;120 million €/year for EU15.Assures a polyvalent platform for regenerative technologies;Assures positive cash flow and supports leveraging of R&D pipeline.
28Stemmatters Life Banking | Stem cell isolation and storage services CompetitionStemmatters Life Banking | Stem cell isolation and storage servicesNewbornsChildrenAdultsEuropeCrioestaminal, Bioteca, Bebé Vida, Criovida, Cytothera (Portugal)Celvitae, Vidacord, Secuvita, Vidaplus, Stem Cell, CrioCord, Safetycord (Spain)ActiVision Life (Poland), Babycord (Cyprus), Babycord (Turkey), Biohellenica (Greece), Biophylaxis (Greece), BPK (Slovenia), CopyGene (Denmark), CryoBank (Turkey), Cryo-Save (Belgium), Cryomedica (Russia), Eticur (Germany), Eurocord (Slovakia), Floramed (Russia), Gemabank (Russia), GenKord (Turkey), Hemafund (Ukraine), In Scientia Fides (Italy), Krio (Hungary), Liaison (Greece), LifeBank (Cyprus), Lifecord (Austria), Lifeline (Cyprus), LongaVita (Poland), Polish Stem Cell Bank (Poland), Progenis (Poland), RCB (Switzerland), Seracell (Germany), SmartBank (Italy), StellaCure (Germany), Stemcare (Denmark), Stem-Health Hellas (Greece), VITA34 (Germany), Vitacord (Austria), Yasam Bankasi (Turkey), Cells4Life (UK), Cells Limited (UK), CryoGENESIS (UK), Future Health Technologies (UK), SmartCells (UK), UK Cord Blood Bank (UK), UK Health Solutions (UK), Virgin Health Bank (UK)Bioeden (UK)StemmattersCytothera (Portugal)Cryo-Save (Belgium)Cytori TherapeuticsBiohellenika (Greece)USAAlphaCord, CordBancUSA, Cord Blood America, Cord Blood Registry, Cord Blood Solutions, Cryobanks International, Cryo-Cell International, DomaniCell, Elie Katz, Family CB Services, Family Link, Genesis Bank, HemaStem, LifebankUSA, LifeLine, LifeSource, MAZE Labs, Neocells, Newborn Blood Banking, New England CB Bank, RMI, Safetycord, Securacell, StemCyte, Stork Medical, Utah Cord Bank, Viacord, Vista Cord, XytexBioeden, StemSave, Baby Teeth Cell BankCryo-cellNeostem
29Stemmatters Life Banking | Stem cell isolation and storage services Current OfferingStemmatters Life Banking | Stem cell isolation and storage servicesAcquisition DriversIncreased value of the surgical procedure;Potential application in future autologous regenerative therapies;Allows for off the shelf availability of personalized regenerative products;Decreases time for clinical delivery of therapy.Current applications of adipose derived adult stem cellsRadiation NecrosisBreast ReconstructionHeart AttackChronic Heart DiseaseCrohn’s DiseaseTracheal Fistula HealingCalvarial RepairMarrow Transplant ComplicationsDiabetes
31Stemmatters Biomedical | Products and services for R&D Current OfferingIsolation and processing services of human cells:Human stromal vascular fraction isolated from adipose tissue containing human adipose derived stem cells (all samples are characterized for cell number and viability);Human adipose derived stem cells (all samples are characterized for cell number and viability, as well as multipotent mesenchymal stem cell markers: CD29, CD105, CD34 and CD45);Pre-clinical research in regenerative medicine accounts for a market volume of about 700 million €/year.Cell culturing products;Hydrogel support systems for 3D cell culturing;Very high R&D visibility among the potential buyer community;The global market potential for the commercialization of 3D supports for non-clinical R&D is estimated to worth between 7 and 35 million €/year.Device for dynamic cell seeding and culturing.Stemmatters Biomedical | Products and services for R&D