Fa'amatalaga Fa'afoma'i Lelei mai Su'esu'ega o Togafitiga Cell mo Fa'ama'i Degenerative Disc

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Avatar a Linda Hohnholz

DiscGenics, Inc., o se kamupani biopharmaceutical tulaga falemaʻi e taulaʻi i le atinaʻeina o togafitiga faʻasolosolo faʻavae e faʻaitiitia ai le tiga ma toe faʻafoʻisia galuega i tagata mamaʻi faʻamaʻi faʻamaʻi o le tui, na faʻasalalau i aso nei le tuʻuina atu o faʻamatalaga lelei le tumau mai lona faʻaauauina o le Phase 1/2 faʻataʻitaʻiga faʻataʻitaʻiga. o le IDCT (rebonuputemcel), o le allogeneic injectable discogenic cell therapy mo le degenerative disc disease (DDD), ile Spine Summit 2022.    

O le pito sili ona aoga o le suʻesuʻega (n = 60) na ausia, faʻatasi ai ma le faʻaleleia atili o fuainumera i tiga i tua o loʻo matauina i le vaega maualuga o le IDCT. Mo nei maʻi, faʻaleleia le maualalo o le tiga i tua> 30% e pei ona fuaina i luga ole 100mm Visual Analog Scale (VAS) i Vaiaso 12 (-54.53% [-69.46, -39.60], p = 0.0056), 26 (-50.94% [- 66.10, -35.78], p=0.0140), ma le 52 (-62.79% [-77.13, -48.46], p=0.0005).

I nei lava taimi e tasi, o le maualuga o le IDCT na maua ai foʻi le faʻaleleia atili o le falemaʻi, faʻafuainumera taua faʻaleleia galuega e pei ona fuaina e le Oswestry Disability Index (ODI) ma le lelei o le olaga e pei ona fuaina e le EQ-5D Index Score.

O le mea e sili ona taua, e leai ni mataupu ile vaega ole togafitiga IDCT na feagai ma togafitiga ogaoga-faʻalavelave faʻalavelave faʻafuaseʻi (TEAEs).

"E matua faʻamalosia i matou i lenei faʻamatalaga le tumau falemaʻi. E le gata o loʻo matou vaʻai i se faʻamatalaga malosi o le saogalemu ma le faʻaitiitia o tiga faʻapitoa ma se tali faʻamaʻi e tupu vave ma faʻaauau i le tasi le tausaga taimi i tagata mamaʻi na maua le IDCT maualuga, o loʻo matou vaʻaia foi le vave, taua, ma le umi o faʻaleleia. i galuega ma tulaga lelei o le olaga, "o le tala lea a Kevin T. Foley, MD, Ofisa Sili Fomaʻi mo DiscGenics ma le Taitaifono o Semmes-Murphy Neurologic & Spine Institute. "A o matou faʻatali i le 78-vaiaso ma le 104-vaiaso faʻamaumauga mulimuli, matou te faʻamoemoe e vaʻaia le faʻaleleia ma le aoga i nei faiga e suia ai olaga."

O le faʻaleleia atili o le tiga, galuega, ma le lelei o le olaga i le tausaga e tasi pe a maeʻa le tui na sili atu nai lo le mea e taʻua o eseesega taua o le falemaʻi (MCIDs), lea e atagia mai ai suiga i se faʻalavelave faʻapitoa e aoga mo le maʻi.

"O le faʻaleleia atili ma le umi o loʻo tatou vaʻaia i le tiga, galuega, ma le lelei o le olaga o faʻailoga taua ia o le IDCT e ono suia ai le faʻataʻitaʻiga o le tausiga o tagata mamaʻi ma le DDD," o le tala lea a Flagg Flanagan, Ofisa Sili o Pulega ma le Taitaifono o le Komiti Fa'atonu mo DiscGenics. "I le avea ai ma tausimea o lenei tekinolosi, o le au tuuto ma le talenia iinei i le DiscGenics o loʻo galulue ma le le vaivai e faʻafeiloaʻi le IDCT e ala i le falemaʻi ma le faʻatonutonuina o faiga faʻapisinisi, ma le sini autu o le faʻaleleia o olaga o le faitau miliona o tagata o loʻo mafatia i aafiaga faʻavaivaia o le maualalo o taimi. tiga i tua.”

DiscGenics o loʻo faʻagasolo le suʻeina o faʻamatalaga mai asiasiga tulitatao maʻi i vaiaso 78 ma 104. Ua faʻamoemoe le Kamupani e tuʻuina atu faʻamaumauga atoa i le US Food & Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) mo le iloiloga i totonu. se fonotaga Fa'ai'uga o le Vaega 2 fa'atatau mo le afa lona lua o le 2022.

I le taimi nei, DiscGenics o loʻo faʻaauauina le faʻalauteleina o ana gaosiga i totonu o le fale ina ia mafai ai ona saunia sela mo le lumanaʻi falemaʻi ma / poʻo pisinisi faʻatau, faʻatatau i le taunuuga o le iloiloga a le FDA o faʻamaumauga.

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Avatar a Linda Hohnholz

Linda Hohnholz

Faatonu sili mo eTurboNews fa'avae ile eTN HQ.

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