Tobetsa mona ho bonts'a lifolakha tsa HAO leqepheng lena mme u lefelle katleho feela

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Positive Clinical Data ho tsoa ho Thuto ea Cell Therapy for Degenerative Disc Disease

ngotsoeng ke mohlophisi

DiscGenics, Inc., k'hamphani ea kliniki ea biopharmaceutical e tsepamisitseng maikutlo ho nts'etsopele ea liphekolo tse nchafalitsoeng tse thehiloeng liseleng tse fokotsang bohloko le ho khutlisetsa ts'ebetso ho bakuli ba nang le mafu a sa foleng a lesapo la mokokotlo, kajeno e phatlalalitse tlhahiso ea lintlha tse ntle tsa nakoana ho tsoa tekong ea eona ea bongaka ea Phase 1/2. ea IDCT (rebonuputemcel), allogeneic injectable discogenic cell therapy for degenerative disc disease (DDD), ho Spine Summit 2022.    

Qetellong ea katleho ea thuto (n = 60) e ile ea finyelloa, ka ntlafatso ea lipalo-palo ea bohloko ba morao bo hlokometsoeng sehlopheng se phahameng sa IDCT. Bakeng sa bakuli bana, lintlha tse bohloko tsa morao li ile tsa ntlafatsoa> 30% ha e lekantsoe ka 100mm Visual Analog Scale (VAS) ka Libeke 12 (-54.53% [-69.46, -39.60], p = 0.0056), 26 (-50.94% [-] 66.10, -35.78], p=0.0140), le 52 (–62.79% [–77.13, -48.46], p=0.0005).

Linakong tsena tsa nako, IDCT ea tekanyo e phahameng e boetse e hlahisitse lintlafatso tse nang le moelelo oa bongaka, lipalo-palo mosebetsing joalokaha ho lekantsoe ke Oswestry Disability Index (ODI) le boleng ba bophelo bo lekantsoeng ke EQ-5D Index Score.

Habohlokoa, ha ho batho ba lihlopheng tsa kalafo tsa IDCT ba bileng le liketsahalo tse mpe tse hlahang kalafong (TEAEs).

"Re khothatsoa haholo ke lintlha tsena tsa nakoana tsa bongaka. Hase feela hore re bona boemo bo matla ba tšireletso le phokotso e tsotehang ea bohloko ka karabo ea tekanyo e hlahang pele ho nako 'me e tsoela pele ka nako ea selemo se le seng ho bakuli ba fumaneng tekanyo e phahameng ea IDCT, re boetse re bona ntlafatso e potlakileng, ea bohlokoa le e tšoarellang. ts'ebetsong le boleng ba bophelo, "ho boletse Kevin T. Foley, MD, Mookameli oa Kalafo ea ka Sehloohong bakeng sa DiscGenics le Molula-setulo oa Semmes-Murphy Neurologic & Spine Institute. "Ha re ntse re letetse ho baloa ha data ea ho qetela ea libeke tse 78 le libeke tse 104, re tšepa ho bona ntlafatso e tsitsitseng le e nang le morero ho e 'ngoe le e 'ngoe ea mehato ena e fetolang bophelo."

Lintlafatso tsa bohloko, ts'ebetso le boleng ba bophelo ka mor'a selemo se le seng ka mor'a ente li fetisitse se tsejoang e le phapang e fokolang ea bohlokoa ea bongaka (MCIDs), e bontšang liphetoho tsa ho kenella ka kliniki tse nang le moelelo ho mokuli.

"Lintlafatso tsa bohlokoa le tse tšoarellang tseo re li bonang bohlokong, ts'ebetsong, le boleng ba bophelo ke matšoao a bohlokoa a hore IDCT e ka fetola pono ea tlhokomelo ho bakuli ba nang le DDD," ho boletse Flagg Flanagan, Ofisiri e ka Sehloohong le Molula-setulo oa Mokhatlo. Boto ea DiscGenics. "Joaloka batsamaisi ba theknoloji ena, sehlopha se inehetseng le se nang le talenta mona DiscGenics se sebetsa ka thata ho tlisa IDCT ka ts'ebetso ea bongaka le taolo ea khoebo, ka sepheo sa mantlha sa ho ntlafatsa maphelo a batho ba limilione ba nang le litlamorao tse fokolisang tsa bofokoli bo sa foleng. bohloko ba mokokotlo.”

DiscGenics e mothating oa ho sekaseka lintlha tse tsoang maetong a ho latela bakuli libekeng tsa 78 le 104. Khampani e ikemiselitse ho fana ka dataset e felletseng ho US Food & Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) bakeng sa ho hlahlojoa. Qetello ea kopano ea Mokhahlelo oa 2 e reretsoeng halofo ea bobeli ea 2022.

Ho sa le joalo, DiscGenics e ntse e tsoela pele ho eketsa bokhoni ba eona ba ho etsa ka tlung kahoo e tla ba le lisele tse lokiselitsoeng bakeng sa ts'ebeliso ea nako e tlang ea bongaka le / kapa ea khoebo, ho latela sephetho sa tlhahlobo ea data ea FDA.

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mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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