Margaret Mead, anthropologist Margaret Mead, famously mused that in her view, the first evidence of civilization wasn't architecture, wasn't tools, but rather a 15,000-year-old fossil of a healed fracture. Evidence that someone else had taken the time to help the injured person to safety and through recovery.
Margaret Mid, antropološkinja Margaret Mid, čuveno je njeno mišljenje da prvi dokaz civilizacije nije arhitektura, ni oruđe, već fosil sa zaraslim prelomom star 15 000 godina. Dokaz da je neko drugi uložio vreme da pomogne povređenoj osobi da bude bezbedna i da se oporavi.
Fast forward 15,000 years, and medical science has brought many advances. Many of us are projected here in this audience to live until 115 years old. It gets people like me thinking, as we go through this lifetime, because our methods of repairing the human body still, no offense, look a lot like carpentry, we're all going to be acquiring parts of our bodies that we weren't born with. If we haven't already.
Premotajmo unapred 15 000 godina, i medicinska nauka je donela mnoštvo prednosti. Mnogima od nas iz publike je predviđeno da žive i do 115 godina. Tera ljude poput mene na razmišljanje, dok koračamo kroz ovaj život, jer naše metode popravljanja ljudskog tela još uvek, bez uvrede, dosta liče na stolarstvo, svi ćemo da nabavljamo delove tela sa kojima nismo rođeni. Ako već nismo.
This wouldn't be a problem, except we're getting injured earlier in life and living longer and longer. Bone is the most transplanted human material after blood, and as a society, we are replacing millions of joints per year because of just a couple millimeters of damaged cartilage. None of this would be a problem, except for getting injured earlier in life and living longer and longer. And the earlier we get implants, the less time they last. And these trends are globalizing. I mean, it's enough to make you hysterical. People like me, you know, I've thought we need our implants to last as long as we do.
To ne bi bio problem da ne zadobijamo povrede sve ranije u životu, a živimo sve duže. Kost je ljudski materijal koji se najviše presađuje posle krvi, i kao društvo, zamenjujemo milione zglobova godišnje zbog nekoliko milimetara oštećene hrskavice. Ovo ne bi bio problem da ne zadobijamo povrede sve ranije u životu, a živimo sve duže. I što ranije dobijemo implantate, to oni kraće traju. I ovo postaje globalni trend. Mislim, dovoljno je da postanete histerični. Ljudi poput mene, znate, misle da nam trebaju implantati da traju onoliko dugo koliko živimo.
I'm a biomedical engineer, and over a decade ago, I first came to this stage to talk about our approach to building upon this cornerstone of human civilization, repairing the human body, using cells as an ingredient to grow living and atomically precise spare parts for the human body that function on day one, fit perfectly and last as long as we do. And in 2014, I, with others, launched a company called EpiBone with the help of many TEDsters, some of whom are actually here in this audience -- yes -- to test this approach in humans for bone and cartilage. And I'm here to give you an update to tell you how far we've come. So here's how it works. We start from a CT scan from which we can extract three-dimensional data, and using digital fabrication techniques like 3D printing and 3D milling, make a perfect puzzle piece shaped biomaterial scaffold, infuse it with adult stem cells and cultivate it in what we call a bioreactor. A bioreactor is really just a fancy word for our proprietary cell culture robots that mimic the conditions of the human body, providing controlled delivery of oxygen, nutrients and mechanical forces. So you can think of this as kind of diet and exercise that get the stem cells to attach to the scaffold, proliferate and, most importantly, differentiate. It takes us three weeks to engineer bone, four weeks to engineer cartilage, and we have a platform technology that allows us to engineer bones or joints throughout the body.
Ja sam biomedicinski inženjer, i pre više od decenije, prvi put sam došla na ovu binu da pričam o našem pristupu koji se gradi na ovom temelju ljudske civilizacije, popravljanju ljudskog tela, koristeći ćelije kao sastojak za gajenje živih i atomski preciznih rezervnih delova za ljudsko telo koji rade odmah, savršeno se uklapaju i traju dokle trajemo i mi. Sa ostalima sam 2014, pokrenula kompaniju EpiBone uz pomoć mnogih Tedsterovaca, od kojih su neki čak i ovde u publici - da - da testiraju ovaj pristup kod ljudi za kosti i hrskavicu. I dolazim sa novostima da vam kažem dokle smo stigli. Evo kako funkcioniše. Počinjemo od CT snimka, odakle možemo da izvučemo trodimenzionalne podatke, i upotrebom tehnika za digitalnu izradu kao što su 3D štampač i 3D glodalica, pravimo savršenu skelu od biomaterijala u vidu slagalice, ispunimo je odraslim matičnim ćelijama i uzgajamo je u onome što zovemo bioreaktor. Bioreaktor je samo otmena reč za naše robote za kulturu ćelija koji oponašaju uslove ljudskog tela, obezbeđujući kontrolisanu dostavu kiseonika, nutrijenata i mehaničkih sila. Možete ovo da posmatrate kao neku vrstu dijete i vežbe koje pomažu matičnim ćelijama da se prikače za skelu, razmnože i, što je najbitnije, diferenciraju. Potrebne su tri nedelje da napravimo kost, četiri nedelje da napravimo hrskavicu, a imamo i tehnološku platformu koja nam omogućava da pravimo kosti ili zglobove u celom telu.
2021 we made history as the first biotechnology company greenlit by the FDA to use this approach in human, taking stem cells, turning them into tissues, putting those tissues into people. And we did this for six patients in our phase 1.2 historic human clinical trial. And we replaced jawbones in those patients. And what I can tell you is that now, almost two years since we've implanted our first patient, whether the patients were 18, 59, male, female, suffering from congenital defects or trauma, at Cleveland Clinic, the San Francisco VA or UT San Antonio, we're seeing the same thing. The grafts fit perfectly, integrate seamlessly with no adverse events, but perhaps even more importantly, the patients are eating, speaking, sleeping normally because these are the measurements that really matter. You know, for people like me who've been working on this for two decades, you know, science is built on the shoulders of giants. And I joined teams that had been working on this for decades prior. You can imagine how we feel to be finally making this one step forward towards making good on our mission, which is to improve patient lives.
Ušli smo u istoriju 2021. kao prva biotehnološka kompanija kojoj je Uprava za hranu i lekove odobrila da koristi ovaj pristup kod ljudi, uzima matične ćelije, pretvara ih u tkiva, i stavlja ta tkiva u ljude. Uradili smo ovo za šest pacijenata u našoj 1.2 fazi istorijskog kliničkog ispitivanje na ljudima. Zamenili smo viličnu kost kod ovih pacijenata. I mogu vam reći da sada, skoro dve godine nakon ugradnje implantata u našeg prvog pacijenta, bilo da su pacijenti imali 18, 59, muškarci, žene, patili od urođenih mana ili trauma, na klinici u Klivlendu i San Francisku ili univerzitetu u San Antoniju, primećujemo istu stvar. Transplantati se savršeno uklapaju, besprekorno se spajaju bez neželjenih dejstava, ali možda čak i najbitnije, pacijenti jedu, govore, normalno spavaju jer su ovo mere koje su stvarno bitne. Znate, ljudi kao ja koji rade na ovome dve decenije, znate, nauka je izgrađena na ramenima divova. Postala sam deo timova koji su radili na ovome prethodnih decenija. Možete da zamislite kako se osećamo što smo konačno napravili pomak ka ostvarenju naše misije, a to je poboljšanje života pacijenata.
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We are in the process now of applying for permission from FDA to repeat this success in a much larger, game-changing market of knee cartilage. Many of us here in the audience need it now if we don't have already had our joints replaced. So I really hope to be able to come back in a few years' time and tell you we've made good on this expanded mission.
Sada smo u procesu podnošenja zahteva za dozvolu od Uprave za hranu i lekove da ponovimo ovaj uspeh na mnogo većem, inovativnom tržištu hrskavice kolena. Mnogima od nas ovde u publici je potrebna odmah, ako već nismo zamenili svoje zglobove. Nadam se da ću moći da se vratim za nekoliko godina i da vam kažem da smo uspeli u ovoj proširenoj misiji.
So in conclusion, I'd like to invite you to scan your body and imagine all those spare parts of our bodies that we're bound to accumulate as we go through this lifetime. Would we rather have those spare parts made from metal, plastic, ceramic, or rather to connect to our own internal fountain of cellular youth and grow these parts? I'm here to tell you that this possibility is in reach, and that we have every intention of making it happen.
Da zaključim, pozivam vas da skenirate svoje telo i zamislite sve one rezervne delove naših tela čiji će se broj tokom života sigurno povećavati. Da li bismo radije imali rezervne delove napravljene od metala, plastike, keramike ili bismo se radije povezali sa svojom unutrašnjom fontanom ćelijske mladosti i uzgajali ove delove? Ovde sam da vam kažem da je ova mogućnost nadohvat ruke, i da je naša namera da ovo učinimo mogućim.
Thank you so much.
Hvala vam puno.
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