Positive Clinical Data kuchokera ku Study of Cell Therapy for Degenerative Disc Disease

DiscGenics, Inc., kampani yachipatala ya biopharmaceutical yomwe imayang'ana kwambiri pakupanga njira zochiritsira zosinthika zama cell zomwe zimachepetsa ululu ndikubwezeretsa ntchito kwa odwala omwe ali ndi matenda osokonekera a msana, lero alengeza za kuwonetsa kwanthawi yayitali kuchokera ku mayeso ake azachipatala a Phase 1/2. wa IDCT (rebonputemcel), allogeneic injectable discogenic cell therapy for degenerative disc matenda (DDD), ku Spine Summit 2022.    

Mapeto apamwamba a phunzirolo (n = 60) anapindula, ndi kusintha kwakukulu kwa ululu wammbuyo komwe kumawonedwa mu gulu lapamwamba la IDCT. Kwa odwalawa, ululu wochepa wammbuyo umakhala wabwino> 30% monga momwe amachitira pa 100mm Visual Analog Scale (VAS) pa Masabata 12 (-54.53% [-69.46, -39.60], p = 0.0056), 26 (-50.94% [-] 66.10, -35.78], p=0.0140), ndi 52 (–62.79% [–77.13, -48.46], p=0.0005).

Panthawi yomweyi, IDCT ya mlingo waukulu udapanganso kusintha kwabwino kwachipatala, kowerengeka kogwira ntchito monga momwe amayesedwera ndi Oswestry Disability Index (ODI) ndi moyo wabwino monga momwe amayezera EQ-5D Index Score.

Chofunika kwambiri, palibe anthu omwe ali m'magulu a mankhwala a IDCT omwe adakumana ndi zochitika zoopsa zachipatala (TEAEs).

"Ndife olimbikitsidwa kwambiri ndi zomwe zakhala zikuchitika pakanthawi kochepa. Sikuti tikungowona mbiri yachitetezo champhamvu komanso kuchepetsa kupweteka kwambiri ndi kuyankha kwa mlingo komwe kumachitika msanga ndikupitilira chaka chimodzi kwa odwala omwe adalandira IDCT yayikulu, tikuwonanso kusintha kwachangu, kofunikira, komanso kokhazikika. mu ntchito ndi moyo wabwino, "anatero Kevin T. Foley, MD, Chief Medical Officer wa DiscGenics ndi Wapampando wa Semmes-Murphy Neurologic & Spine Institute. "Pamene tikudikirira kuwerengedwa komaliza kwa masabata 78 ndi masabata 104, tikuyembekeza kuwona kusintha kokhazikika panjira iliyonse yosintha moyo."

Kusintha kwa ululu, ntchito, ndi umoyo wa moyo pa chaka chimodzi pambuyo pa jekeseni kuposa zomwe zimadziwika kuti ndizosiyana siyana zachipatala (MCIDs), zomwe zimasonyeza kusintha kwa chithandizo chachipatala chomwe chili ndi tanthauzo kwa wodwalayo.

"Kusintha kwakukulu komanso kokhazikika komwe tikuwona mu zowawa, ntchito, komanso moyo wabwino ndizizindikiro zazikulu za IDCT yomwe ingathe kusintha malingaliro a chisamaliro kwa odwala omwe ali ndi DDD," atero a Flagg Flanagan, Chief Executive Officer ndi Chairman wa Bungwe la DiscGenics. "Monga oyang'anira ukadaulo uwu, gulu lodzipereka komanso laluso kuno ku DiscGenics likugwira ntchito molimbika kubweretsa IDCT kudzera muzachipatala ndi njira zoyendetsera malonda, ndi cholinga chachikulu chokweza miyoyo ya anthu mamiliyoni ambiri omwe akuvutika ndi zofowoka za kuchepa kwachangu. kupweteka kwa msana.”

DiscGenics ili mkati mosanthula deta kuchokera ku maulendo otsatila odwala pa masabata 78 ndi 104. Kampani ikufuna kutumiza deta yonse ku US Food & Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) kuti iganizidwe Mapeto a gawo lachiwiri la msonkhano womwe umayang'ana theka lachiwiri la 2.

Pakadali pano, DiscGenics ikupitiliza kukulitsa luso lake lopanga m'nyumba kuti ikhale ndi maselo okonzekera mtsogolo azachipatala komanso/kapena ntchito zamalonda, kutengera zotsatira za kuwunika kwa data kwa FDA.