Ua hoʻolaha ʻo PolarityTE, Inc. i kēia lā i ke kākau inoa ʻana o ke kumuhana mua i ka Phase III pivotal study loiloi SkinTE i ka hoʻohana noiʻi ʻana i ka mālama ʻana i nā maʻi maʻi wāwae maʻi maʻi Wagner grade 2 (DFUs), i kapa ʻia ʻo "Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE, ” a i ʻole “COVER DFUs.”

E hoʻopaʻa inoa nā COVER DFU a hiki i 100 mau kumuhana a hiki i 20 mau kahua lapaʻau ma ʻAmelika Hui Pū ʻIa. E hoʻokaʻawale ʻia nā kumuhana i kekahi o nā pūʻulu lapaʻau ʻelua, e loaʻa iā SkinTE me ka maʻamau o ka mālama (SOC) a i ʻole ka SOC wale nō. ʻO ka hopena mua ka hopena o nā DFU i pani ʻia ma 24 mau pule. Loaʻa nā helu hope ʻelua i ka hoʻemi ʻāpana ʻāpana (PAR) ma 4, 8, 12, 16 a me 24 pule; ʻoi aku ka maikaʻi o ke ola, e like me ka noho kaʻawale ʻana, ke kaumaha, ka ʻala, ka hoʻomaikaʻi ʻana i ka hana, ka ambulation, a me ka hoʻi ʻana i nā hana e pili ana i nā loli i ka maikaʻi o ke ola ʻeha; a me ka hoʻomaka hou ʻana o ka maʻi o ka DFU e koi ana i ka mālama ʻana me nā lāʻau antibiotic topical a/a i ʻole.

ʻO COVER DFUs ka haʻawina koʻikoʻi mua a PolarityTE e alakaʻi ai ma lalo o kāna IND wehe no SkinTE me kahi hōʻailona no ka mālama ʻana i nā maʻi maʻi maʻi maʻi maʻi (CCUs). ʻO nā CCU nā ʻeha i hiki ʻole ke holomua ma o nā kaʻina hana hoʻoponopono kiko a me ka manawa kūpono e pono ai e hoʻihoʻi i ka hana maʻamau a me ke anatomy o ka ʻili. ʻO nā DFU, nā ʻeha puʻe (PI), a me nā ʻeha wāwae venous (VLU) ka hapa nui o nā CCU, a pili i ka 8 miliona mau maʻi i kēlā me kēia makahiki, a i ʻole ~2% o ka heluna kanaka o ʻAmelika Hui Pū ʻIa (US). Manaʻo ʻia e piʻi aʻe ka nui o ka CCU i ka nui o ka heluna kanaka a me ka piʻi ʻana o ka maʻi diabetes, ka maʻi cardiovascular, a me ka momona. No laila, ke hōʻike nei nā CCU i kahi manawa mākeke nui i kēia manawa, a ke manaʻo nei ʻo PolarityTE e ulu kēia manawa.

Ua ʻōlelo ʻo Richard Hague, Luna Nui, "ʻO ka hoʻopaʻa inoa ʻana i kā mākou kumuhana mua i kahi noiʻi koʻikoʻi ma lalo o kahi IND i ʻae ʻia e FDA he mea koʻikoʻi koʻikoʻi no ka ʻoihana a he hōʻike i ka manaʻo paʻa a me kā mākou hui holoʻokoʻa. Makemake au e hoʻomaikaʻi i kā mākou limahana i hana nui e hiki i kēia wahi, a ʻaʻole hiki iaʻu ke hoʻonui i ka hauʻoli i loko o kā mākou hui e ʻike iā SkinTE e hoʻi i ke keʻena. Haʻaheo loa mākou i ka hoʻomaka ʻana i kā mākou haʻawina koʻikoʻi mua ma Wagner Grade 2 DFUs, e pili pinepine ana i nā hale koʻikoʻi i hōʻike ʻia. ʻO nā poʻe maʻi e loaʻa ana i kēia mau ʻeha paʻakikī he mau koho lapaʻau liʻiliʻi loa a ke lana nei ko mākou manaʻo e hiki i kā mākou noiʻi ʻana ma COVER DFUs ke hoʻolauna i kahi lapaʻau hou e hoʻokō ai i kēia mau mea maʻi i nā pono lapaʻau nui ʻole. Makemake mākou e hoʻomaikaʻi aku i nā kumuhana a me nā mea lapaʻau e komo i COVER DFUs no ke kākoʻo ʻana i kā mākou mau hana e lawe i nā loli kūpono i kēia kaiāulu maʻi.

Ua ʻōlelo ʻo Nikolai Sopko, MD, PhD, Luna Nui ʻepekema, "ʻO ke ʻano o nā ʻeha a mākou e ʻimi nei me kā mākou CCU hōʻailona ke hoʻomau mau nei no nā makahiki, a ʻaʻole i hoʻōla ʻia kekahi no nā makahiki he mau makahiki. Ma muli o ko lākou hoʻomau mau ʻana, hoʻonui nā CCU i ka nāwaliwali o ka mea maʻi i ka maʻi a loaʻa i ka maʻi maʻi a me ka make nui, i hoʻonui ʻia i nā ʻeha nui a i ʻole nā ʻeha e hoʻonui i ka hohonu. No kēia poʻe maʻi, aia ka hiki maoli o ka ʻoki ʻana i nā lālā piha a ʻāpana paha me ke kino kīnā. ʻEwalukūmālima pākēneka o nā ʻoki ʻoki ʻana i nā lālā non-traumatic e pili ana me CCU, me ka manaʻo o ka ʻoki ʻana i nā lālā i kēlā me kēia 30 kekona. Ua hoʻomau ʻo Kauka Sopko, "Makemake wau e hoʻomaikaʻi nui i kā mākou hui lapaʻau no kā lākou hoʻoikaika ʻole ʻana e lawe iā mākou i kēia koʻikoʻi koʻikoʻi no SkinTE, a ke kakali nei mākou i ka hana ma mua."

ʻO Kauka Felix Sigal, DPM, ka mea noiʻi pūnaewele no ka Los Angeles Foot & Ankle Clinic kahi i kākau inoa ʻia ai ke kumuhana mua ma COVER DFUs. Aia ʻo Kauka Sigal i nā limahana ma ka Halemai ʻo Hollywood Presbyterian a me ka Halemai Lapaʻau o Kaleponi, kahi āna i kālele ai i ka mālama ʻana i ka ʻeha, ka hoʻōla ʻana o nā lālā maʻi diabetic, a ke ʻimi nei i kona hoihoi i ka noiʻi lapaʻau e hiki ai i ka hoʻomohala ʻana i nā koho lapaʻau maikaʻi loa no kāna mau maʻi. ʻO Kauka Sigal kekahi o nā loea kaulana loa ma ke kula a lawelawe ʻo ia ma ke ʻano he ʻimi noiʻi nui ma nā noiʻi noiʻi lapaʻau he nui ma ke kahua o nā pilikia maʻi maʻi a me ka mālama ʻana i nā ʻeha.

'Ōleloʻo Kauka Sigal, "ʻO nā maʻi e loaʻa ana i ka DFUs, a me ka poʻe i loaʻa i ka Wagner 2 DFUs, makemake nui lākou i nā koho hou a hoʻomaikaʻiʻia e hoʻoponopono i ko lākou mau pono olakino nui a kūponoʻole. ʻO ka manawa pinepine, ʻike mākou i kēia mau maʻi e holomua ana a hiki i kahi e koi ai i ka ʻoki ʻana, a ma ke ʻano he mea hoʻolako ke ʻimi mau nei mākou i nā hopena e hoʻomaikaʻi ai i nā hopena no kā mākou mau maʻi. Ma hope o koʻu ʻike ʻana me SkinTE i ka hoʻāʻo ʻana i ka hoʻāʻo hoʻokele randomized hope loa e loiloi ana i ka SkinTE ma Wagner grade 1 DFUs, hauʻoli wau e komo i ke aʻo ʻana o COVER DFUs, he hana koʻikoʻi ia i ka loiloi ʻana i kahi hopena kūpono no kēia mau maʻi i pilikia nui.

He aha e lawe ʻia mai kēia ʻatikala:

Richard Hague, Chief Executive Officer, commented, “Enrolling our first subject in a pivotal study under an FDA-accepted IND is a critical milestone for the company and a testament to the determination and commitment of our entire team.
Sigal is currently on staff at both the Hollywood Presbyterian Hospital and the California Hospital Medical Center, where he focuses on wound care, diabetic limb salvage, and pursues his interest in clinical research to enable development of better treatment options for his patients.
Sigal is one of the most distinguished specialists in the field and serves as a Principal Investigator on numerous clinical research studies in the field of diabetic complications and wound care.