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IAvatar kaLinda Hohnholz
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I-PolarityTE, Inc. namhlanje ibhengeze ukubhaliswa kwesifundo sokuqala kwiSigaba se-III esibaluleke kakhulu sophononongo oluvavanya i-SkinTE kuphando lokusetyenziswa kwonyango lwe-Wagner grade 2 ye-diabetic foot ulcers (DFUs), enesihloko esithi "Ukuvalwa okufunyenweyo ngeVascularized Epithelial Regeneration for DFUs with SkinTE, ” okanye “INQAKU ii-DFUs.”     

I-COVER DFUs iya kubhalisa ukuya kutsho kwi-100 kwizifundo ukuya kutsho kwii-20 sites clinical e-United States. Izifundo ziya kuba zingenamkhethe kwelinye lamaqela amabini onyango, ukufumana nokuba yi-SkinTE kunye nomgangatho wokhathalelo (SOC) okanye i-SOC yodwa. Isiphelo esiphambili sisiganeko se-DFUs esivaliweyo kwiiveki ze-24. Isiphelo sesibini sibandakanya ipesenti yokunciphisa indawo (PAR) kwi-4, 8, 12, 16 kunye neeveki ze-24; umgangatho wobomi obuphuculweyo, kubandakanywa ukuzihlukanisa kwintlalontle, ukudandatheka, ukuvumba, ukuphuculwa komsebenzi, i-ambulation, kunye nokubuyela kwimisebenzi esekelwe kwiinguqu kumgangatho wenxeba lobomi; kunye nosulelo olutsha lwe-DFU olufuna unyango nge-topical kunye / okanye i-antibiotics yenkqubo.

I-COVER DFUs luphononongo lokuqala olubalulekileyo oluya kuqhutywa yi-PolarityTE phantsi kwe-IND evulekileyo ye-SkinTE kunye nesalathiso sonyango lwezilonda ezingapheliyo ze-cutaneous (CCUs). Ii-CCU ziyizilonda eziye zahluleka ukuqhubela phambili ngeenkqubo ezicwangcisiweyo kunye nexesha elifanelekileyo lokulungiswa kwezicubu eziyimfuneko ukubuyisela umsebenzi oqhelekileyo kunye ne-anatomy yesikhumba. I-DFUs, ukulimala koxinzelelo (PI), kunye nezilonda zomlenze we-venous (VLU) zenza uninzi lwe-CCUs, kwaye zichaphazela izigulane eziqikelelwayo ze-8 ngonyaka, okanye ~ 2% yabantu base-United States (US). Ukuxhaphaka kwe-CCU kulindeleke ukuba kwandiswe njengoko iminyaka yabantu kunye nesifo seswekile, isifo senhliziyo, kunye nokukhuluphala kuqhubeka nokunyuka. Ngokufanelekileyo, ii-CCU zimele ithuba elikhulu lentengiso ngoku, kwaye iPolarityTE ilindele ukuba elo thuba likhule.

URichard Hague, iGosa eliLawulayo eliyiNtloko, uthe, "Ukubhalisa isifundo sethu sokuqala kwisifundo esibalulekileyo phantsi kwe-IND eyamkelwe yi-FDA linyathelo elibalulekileyo kwinkampani kunye nobungqina bokuzimisela nokuzibophelela kweqela lethu lonke. Ndingathanda ukubulela abasebenzi bethu abaye basebenza nzima ukufikelela kweli nqanaba, kwaye andinakukwazi ukuwugqithisa uchulumanco olungaphakathi kumbutho wethu wokubona i-SkinTE ibuyela ekliniki. Sinebhongo ngakumbi ngokuphehlelela isifundo sethu sokuqala esibalulekileyo kwii-DFU zeBanga lesi-2 zeWagner, ezihlala zibandakanya izakhiwo ezibalulekileyo. Izigulana ezithwaxwa ngala manxeba acela umngeni zineendlela zonyango ezinqongophele kakhulu kwaye sinethemba lokuba uphando lwethu kwi-COVER DFUs lungazisa unyango olutsha ukuzalisekisa iimfuno zonyango ezingafezekiswanga zezi zigulana. Sifuna ukubulela kwizifundo kunye nababoneleli bezonyango abaza kuthatha inxaxheba kwi-COVER DFUs ngokuxhasa iinzame zethu zokuzisa utshintsho olunentsingiselo kolu luntu lwezigulane.” 

U-Nikolai Sopko, MD, PhD, iGosa eliyiNtloko lezeNzululwazi, uthe, "Uhlobo lwamanxeba esijolise kuwo nge-CCU yethu ebonisayo luhlala luhlala iminyaka, kwaye amanye ahlala engaphiliswa amashumi eminyaka. Ngenxa yokungaguquguquki kwazo, ii-CCUs zonyusa ukuba sesichengeni sesigulana sosulelo kwaye zinezigulo ezibalulekileyo kunye nomngcipheko wokufa, onyuswa kumanxeba amakhulu okanye amanxeba afikelela kubunzulu obukhulu. Kwezi zigulana, kukho elona thuba lokwenyani lokunqunyulwa kwelungu elipheleleyo okanye inxenye kunye nokukhubazeka okunxulumeneyo. Amashumi asibhozo anesihlanu ekhulwini okunqunyulwa kwemilenze engeyongozi anxulunyaniswa neCCU, kuqikelelwa ukuba kunqunyulwa amalungu rhoqo ngemizuzwana engama-30.” UGqr. Sopko uqhubeke wathi, "Ndingathanda ukubulela ngokungazenzisiyo iqela lethu leklinikhi ngeenzame zabo ezingadinwayo zokusizisa kweli nqanaba libalulekileyo le-SkinTE, kwaye sijonge phambili kumsebenzi ongaphambili." 

UGqr. Felix Sigal, DPM, ngumphandi wendawo ye-Los Angeles Foot & Ankle Clinic apho isifundo sokuqala sabhaliswa kwi-COVER DFUs. UDkt. Sigal okwangoku kubasebenzi kwiSibhedlele saseHollywood Presbyterian kunye neZiko lezoNyango zeSibhedlele saseCalifornia, apho ugxininise ekunyamekelweni kwesilonda, ukuhlenga imilenze yesifo sikashukela, kwaye ulandele umdla wakhe kuphando lweklinikhi ukwenzela ukuba kuphuhliswe iindlela ezingcono zonyango kwizigulane zakhe. UGqr. Sigal ungomnye weengcali ezibalaseleyo kwintsimi kwaye usebenza njengoMphandi oyiNtloko kwizifundo ezininzi zophando lwezonyango kwinkalo yeengxaki zesifo seswekile kunye nokunakekelwa kwesilonda.

UGqr. Sigal waphawula, "Izigulana eziphethwe yi-DFUs, kwaye ngakumbi abo babandezeleka nge-Wagner 2 DFUs, bafuna ngokukhawuleza iindlela ezintsha kunye neziphuculweyo zokujongana neemfuno zabo zonyango ezinkulu kunye nezingafezekiyo. Ngokufuthi kakhulu, sibona ezi zigulana ziqhubela phambili ukuya kwinqanaba lokufuna ukunqunyulwa, kwaye njengababoneleli sihlala sifuna izisombululo zokuphucula iziphumo kwizigulane zethu. Ukulandela amava am kunye ne-SkinTE kulingo lokugqibela olulawulwa ngokungenamkhethe oluvavanya i-SkinTE kwi-Wagner grade 1 DFUs, ndiyavuya ukuthatha inxaxheba kuphononongo lwe-COVER DFUs, elinyathelo elibalulekileyo lokuvavanya isisombululo esinokubakho kwezi zigulana ziswele kakhulu. "

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IAvatar kaLinda Hohnholz

Linda Hohnholz

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