Sabon dasawa don guringuntsi da lahani na Osteochondral

CartiHeal Ltd. a yau ta sanar da cewa Hukumar Abinci da Magunguna ta Amurka (FDA) ta ba da izinin Premarket Approval (PMA) don shigar da Agili-C™.         

Ana nuna abin da aka sa a cikin jama'a na gyarawa na duniya (icRs) Standars III ko sama da gwiwa na 1-7cm2, ba tare da mummunan maganin Osteoarthritis (Kellgren-Lawrence fo 0-3 ).

An ba da izinin PMA bisa sakamakon binciken IDE mai mahimmanci na shekaru biyu. Binciken ya tabbatar da fifiko na Agili-C ™ da aka saka akan Tsarin Kulawa na yanzu (SSOC) - microfracture da debridement, don maganin cututtukan haɗin gwiwa na gwiwa, chondral da lahani na osteochondral. Binciken ya kasance multicenter, 2: 1 bazuwar, buɗaɗɗen lakabi da sarrafawa. An shigar da jimillar batutuwa 251, 167 a hannun Agili-C™, da 84 a hannun SSOC, a cikin shafuka 26 duka a ciki da wajen Amurka.

Babban mahimmanci na binciken shine canji daga asali zuwa watanni 24 a cikin matsakaicin raunin Knee da kuma Sakamakon Sakamakon Osteoarthritis (KOOS Gabaɗaya), wanda ya ƙunshi ƙananan ƙananan 5: Pain, Sauran Alamun, Ingantacciyar Rayuwa (QOL), Ayyukan Rayuwa na yau da kullum. (ADL) da Wasanni. Sakamakon Gabaɗaya KOOS ya tashi daga 0 zuwa 100, inda mafi girman ƙima ke wakiltar kyakkyawan sakamako.

Bayanan da aka samo daga gwajin sun nuna fifiko na Agili-C™ zuwa tsarin kulawa na yanzu (debridement ko microfracture, SSOC). Yiwuwar fifikon Bayesian na baya bayan watanni 24 an ƙaddara ya zama 1.000, ya zarce ƙayyadaddun ƙididdiga na 0.98 da ake buƙata don nuna fifiko.

• Makin asali na KOOS Gabaɗaya ya kasance iri ɗaya a cikin ƙungiyoyin biyu: 41.2 a hannun Agili-C™ da 41.7 a hannun SSOC. A watan 24, KOOS Gabaɗaya ya inganta zuwa 84.3 a cikin hannun Agili-C ™ idan aka kwatanta da 62.0 don hannun SSOC.

• Matsayin haɓakawa na Agili-C ™ idan aka kwatanta da SSOC ya kasance daidai ga batutuwa tare da Osteoarthritis Mild-moderate (Kellgren-Lawrence Grades na 2 ko 3) kuma ga batutuwa tare da Large Lesions (dukakken wuraren raunuka mafi girma fiye da 3 cm2).

• An tabbatar da fifikon abin da aka saka Agili-C™ akan SSOC a cikin dukkan wuraren ƙarshen binciken na biyu Tabbataccen Maƙasudin Ƙarshen: KOOS Pain, KOOS ADL da KOOS QOL da Rate Mai amsawa.

• Adadin mai amsawa, wanda aka bayyana a-priori azaman haɓakawa na aƙalla maki 30 a cikin KOOS Gabaɗaya a cikin watanni 24 idan aka kwatanta da asali, shine 77.8% a hannun Agili-C™ idan aka kwatanta da 33.6% a cikin hannun SSOC.

Nir Altschuler, wanda ya kafa CartiHeal kuma Shugaba ya ce "Sakamakon binciken na shekaru 2, wanda ya nuna fifikon dasa Agili-C ™ akan tsarin aikin tiyata na yanzu, yana ba da fa'ida mai mahimmanci ga miliyoyin marasa lafiya". "Wannan babban ci gaba da aka samu ya yiwu ne saboda goyon bayan masu ba mu shawara, Hogan Lovells, masu ba da shawara na kididdiga, Ƙididdiga na Ƙididdiga na Halitta, da kuma yawancin masu bincike da marasa lafiya da suka shiga cikin karatunmu. Muna godiya da duk taimakonsu. Amincewar FDAs yana ba mu damar fara kasuwanci da samar da ingantacciyar mafita ga marasa lafiya idan aka kwatanta da daidaitattun zaɓuɓɓukan kulawa na yanzu. "