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Ingantattun Bayanan Asibitoci daga Nazarin Farfaɗowar Kwayoyin Halitta don Cututtukan Rage Ragewa

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DiscGenics, Inc., wani kamfani na asibiti na biopharmaceutical wanda ya mayar da hankali kan bunkasa hanyoyin kwantar da hankali na kwayoyin halitta wanda ke rage jin zafi da kuma mayar da aiki a cikin marasa lafiya da cututtukan cututtuka na kashin baya, a yau ya sanar da gabatar da ingantaccen bayanan wucin gadi daga ci gaba da gwajin gwaji na Phase 1/2. na IDCT (rebonuputemcel), alluran allurar rigakafin ƙwayoyin cuta na discogenic don cututtukan diski na degenerative (DDD), a Taron Spine Summit 2022.    

Babban mahimmancin ƙarshen binciken (n = 60) an samu, tare da ingantaccen ƙididdiga a cikin ciwon baya da aka lura a cikin ƙungiyar IDCT mai girma. Ga waɗannan marasa lafiya, ƙananan ciwon baya sun inganta> 30% kamar yadda aka auna akan 100mm Visual Analog Scale (VAS) a Makonni 12 (-54.53% [-69.46, -39.60], p = 0.0056), 26 (-50.94% [-) 66.10, -35.78], p=0.0140), da 52 (-62.79% [-77.13, -48.46], p=0.0005).

A waɗannan lokuta guda ɗaya, babban adadin IDCT kuma ya samar da ma'ana na asibiti, ingantaccen ƙididdiga a cikin aiki kamar yadda aka auna ta Oswestry Disability Index (ODI) da ingancin rayuwa kamar yadda aka auna ta EQ-5D Index Score.

Mahimmanci, babu wani batutuwa a cikin ƙungiyoyin jiyya na IDCT da suka sami mummunan sakamako na gaggawa na gaggawa (TEAEs).

“Muna samun kwarin gwiwa sosai da wannan bayanan asibiti na wucin gadi. Ba wai kawai muna ganin ingantaccen bayanin martaba mai ƙarfi da raguwar raɗaɗi mai ban mamaki tare da amsawar kashi wanda ke faruwa da wuri kuma yana ci gaba a lokacin lokacin shekara guda a cikin marasa lafiya waɗanda suka karɓi babban adadin IDCT, muna kuma ganin haɓakawa mai sauri, mahimmanci, da dorewa. a cikin aiki da ingancin rayuwa, "in ji Kevin T. Foley, MD, Babban Jami'in Kula da Lafiya na DiscGenics da Shugaban Semmes-Murphy Neurologic & Spine Institute. "Yayin da muke jiran karatun karshe na makonni 78 da makonni 104, muna fatan ganin ci gaba mai dorewa da ma'ana a kowane ɗayan waɗannan matakan canza rayuwa."

Haɓakawa a cikin ciwo, aiki, da ingancin rayuwa a cikin shekara guda bayan allura ya wuce abin da aka sani da ƙananan bambance-bambancen mahimmanci na asibiti (MCIDs), wanda ke nuna canje-canje a cikin aikin asibiti wanda ke da mahimmanci ga mai haƙuri.

Flagg Flanagan, Babban Jami'in Gudanarwa da Shugaban Hukumar ta IDCT ya ce "Babban ci gaba mai dorewa da muke gani a cikin zafi, aiki, da ingancin rayuwa sune mahimman alamomi na yuwuwar IDCT ta canza yanayin kula da marasa lafiya tare da DDD," in ji Flagg Flanagan, Babban Jami'in Gudanarwa da Shugaban Hukumar. Hukumar don DiscGenics. "A matsayin masu kula da wannan fasaha, da ƙungiyar da aka sadaukar ta nan a lokacin disgencais ke aiki takaice a cikin asibitoci na ci gaba da haifar da mummunan tasirin da ƙananan ciwon baya."

DiscGenics yana cikin aiwatar da nazarin bayanai daga ziyarar biyo bayan haƙuri a makonni 78 da 104. Kamfanin yana niyyar ƙaddamar da cikakken bayanan ga Ofishin Abinci da Magunguna na Amurka (FDA) Ofishin Nama da Ci Gaban Therapies (OTAT) don la'akari a cikin Ƙarshen taron mataki na 2 wanda aka yi niyya don rabin na biyu na 2022.

A halin yanzu, DiscGenics yana ci gaba da haɓaka ƙarfin masana'anta a cikin gida don haka zai sami sel waɗanda aka shirya don aikace-aikacen asibiti da / ko kasuwanci na gaba, ya danganta da sakamakon bitar bayanan FDA.

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edita

Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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