Ua waiho ʻia ka BLA (Biologics License Application) no ka huahana "HPC-Cord Blood", i ka FDA ma Ianuali 7th, 2022, a ua hoʻolaha ʻia ʻo StemCyte i ka lā 8 Malaki 2022, ua ʻae ʻia ka hoʻouna ʻana e komo i ka loiloi o ka laikini biologics. kaʻina hana.
ʻO ka "HPC-Cord Blood" kahi huahana ʻōuli hematopoietic stem cell i manaʻo ʻia no ka hāʻawi ʻole ʻana i nā kaʻina hana hoʻololi o ka cell hematopoietic progenitor cell i hui pū me kahi regimen preparative kūpono no ka hematopoietic a me ka immunologic reconstitution i nā maʻi me nā maʻi e pili ana i ka ʻōnaehana hematopoietic. Mai ka hoʻohana mua ʻana i ke koko umbilical cord no ka mālama ʻana i nā maʻi Fanconi Anemia i ka makahiki 1988, ua ʻoi aku ma mua o 40,000 kūleʻa i hoʻololi i ke koko umbilical cord ma ka honua holoʻokoʻa no ka mālama ʻana i nā maʻi o ka hematopoietic a me nā ʻōnaehana pale a me nā maʻi metabolic inborn.
I nā makahiki he 20 i hala iho nei, ua hāʻawi aku ʻo StemCyte ma mua o 2,200 mau ʻāpana koko kaula no ka hoʻololi ʻana i 1 i 20 mau maʻi ma ka honua holoʻokoʻa e loaʻa ana i nā hoʻololi koko ʻo umbilical cord. Hoʻokō mau nā huahana a StemCyte i nā kūlana maikaʻi o nā kino hoʻonaʻauao honua a ʻike ʻia a hilinaʻi ʻia he palekana a maikaʻi hoʻi e ka liʻiliʻi o 350 mau kikowaena transplant a puni ka honua me nā kikowaena olakino kaulana e like me: Duke University Hospital, UCLA Medical Center, Taiwan Chang Gung Memorial Halemai, National Taiwan University Hospital.
ʻO StemCyte kahi hui lāʻau lapaʻau regenerative e hoʻomohala nei i nā huahana pipeline cell therapy a me ka hāʻawi ʻana i nā lawelawe waihona kālā pili i ka lehulehu a pilikino. Ma waho aʻe o ka US FDA i ʻae ʻia i ka Phase II multi-national and multi-center clinical trial no kāna hoʻokolokolo ʻana i ka hōʻeha spinal cord, ua komo pū nā laina huahana cell therapy i kekahi mau hoʻokolohua lapaʻau kanaka e holo nei ma waho o ka US no ka mālama ʻana i ka maʻi ischemic stroke. , hahau mau, a me ka lolo lolo. Hoʻolālā ʻia ka hoʻomohala ʻana i kahi immunotherapy maʻi kanesa e hoʻomaka i kēia makahiki. ʻO ka panakō koko kaula a StemCyte he mau lāhui me ka helu hoʻohālikelike no nā poʻe maʻi mai nā lāhui like ʻole i kiʻekiʻe ke kiʻekiʻe i ka hoʻohālikelike ʻia me nā waihona koko kaula lehulehu ʻē aʻe. Manaʻo ʻo StemCyte i ka mālama ʻana i ke koko ʻo umbilical cord i kona mākaukau koʻikoʻi, ʻoiai e ʻimi ikaika ana i nā hōʻailona hōʻailona cell regenerative hou. ʻO ka hana a StemCyte e hoʻomau i ka hoʻomohala ʻana i kona hiki ke hoʻokō i ka pahuhopu o ka hāʻawi ʻana i nā lāʻau lapaʻau ola i nā poʻe maʻi i loaʻa i nā maʻi degenerative a me nā maʻi weliweli ʻē aʻe.
He aha e lawe ʻia mai kēia ʻatikala:
- Since the first successful use of umbilical cord blood to treat Fanconi Anemia patients in 1988, there have been more than 40,000 successful umbilical cord blood transplants worldwide for the treatment of diseases of the hematopoietic and immune systems as well as inborn metabolic diseases.
- In addition to the US FDA approved Phase II multi-national and multi-center human clinical trial for its investigational spinal cord injury treatment, the cell therapy product lines also include several other human clinical trials in progress outside the US for treatment of acute ischemic stroke, chronic stroke, and cerebral palsy.
- Is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system.
