ʻO ka mea maʻi mua i ka hoʻokolohua stem cell no ka mālama ʻana i ka Traumatic Spinal Cord Injury

Ua hoʻopaʻa inoa ʻo Neuroplast i kāna mea maʻi mua i kahi hoʻokolohua lapaʻau Phase II e loiloi i ka maikaʻi o kāna hoʻololi ʻana i ka Neuro-Cells® lapaʻau e manaʻo nei e pale i ka pōʻino hou aʻe i ka ʻōnaehana nerve waena ma hope o ka mālama ʻana i ka Traumatic Spinal Cord Injury (TSCI). Hana ʻia ka hoʻokolokolo ma ka hui pū ʻana me ka Hospital Nacional de Parapléjicos ma Toledo, Sepania. I kēia mau lā, ua hoʻolaha ʻo Neuroplast i nā hopena maʻi Phase I maikaʻi me Neuro-Cells® no ka mālama ʻana no TSCI a loaʻa pū kekahi € 10 miliona (US $ 11.5M) no ke ala e loaʻa ai ka ʻae ʻana o ka mākeke EMA.   

I kēlā me kēia makahiki, ma kahi o 29,000 poʻe ma ʻEulopa a me ʻAmelika e loaʻa i ka TSCI koʻikoʻi, no laila ʻaʻole i loaʻa ka mālama kūpono i kēia manawa. ʻIke pinepine ka poʻe maʻi i ke kīnā o ke ola a me ka hilinaʻi, me ka hopena maikaʻi ʻole i ka maikaʻi o ke ola. Eia kekahi, ua manaʻo ʻia nā kumukūʻai pili no ka lehulehu ma luna o €11.4 biliona ($13 biliona) i kēlā me kēia makahiki.

Me ka manaʻo o ka hāʻawi ʻana i ka manaʻo i ka poʻe i loaʻa i nā maʻi neurodegenerative, ua hoʻomohala ʻo Neuroplast iā Neuro-Cells®, kahi lapaʻau e hoʻohana ana i nā mea maʻi i nā pūnaewele ponoʻī e pale aku ai i ka nalowale o ka hana i ka wā o ka maʻi ma hope o ka hoʻomau ʻana i ka pōʻino i ke kuamoʻo. , e mālama i ka hana, ka neʻe a me ke kūʻokoʻa. ʻO ia hui pū ʻana o a) lapaʻau autologous a me b) noi intrathecal i c) hoʻonohonoho koʻikoʻi ka mea e ʻokoʻa ai ʻo Neuro-Cells®.

Hoʻopaʻa wale ʻia, hoʻopaʻa ʻia i ka placebo ka haʻawina multi-center honua

ʻO ka Phase II clinical trial e alakaʻi ʻia e Principal Investigators Antonio Oliviero, MD, PHD a me Prof. Jörg Mey mai ka Halemai Parapléjicos ma Toledo, Sepania.

ʻO ke aʻo ʻana he hoʻokolohua randomized a placebo-controlled, me kahi hoʻolālā cross-over hana mua a me ka hope. Loaʻa i ka pūʻulu intervention ka Neuro-Cells® i ka sub-acute phase ma hope o ka hoʻomau ʻana i ka trauma, me ʻeono mau mahina ma hope o kā lākou mau hopena mua. E loaʻa i ka hui placebo kahi placebo i ka wā mua, akā e mālama ʻia me Neuro-Cells® ma hope o ka manawa hahai mua ʻeono mahina. ʻO ka hahai ʻana i nā ʻano he nui no nā pūʻulu ʻelua e pili ana i nā ana hopena i hoʻopaʻa ʻia a hoʻopaʻa ʻia ma ka hana kaʻa a me ka sensory a me nā ana koko a me ka cerebrospinal fluid.

Ua ʻōlelo ʻo Antonio Oliviero, MD, PhD, Principal Investigator ma Hospital Nacional de Parapléjicos de Toledo, Sepania, "Ma hope o koʻu hana ʻana ma ke kahua o Spinal Cord Injury no kahi kokoke i iwakālua mau makahiki, hauʻoli wau e hāʻawi i ka hoʻokumu ʻana i ke kuleana o ka transplant cell in ka ho'ōla hana o nā kānaka me ka Spinal Cord Injury. Hauʻoli wau e lilo i ʻāpana o kēia hana hou i ka noiʻi, me Neuroplast.

ʻO ka hoʻokolokolo e pili ana i nā maʻi 16 e hoʻokomo ʻia i ʻeono a ʻewalu mau pule ma hope o ka loaʻa ʻana o ka trauma i ka spinal cord.

Hoʻokō ʻia ka hoʻokolokolo ma lalo o ka ʻae ʻia mai nā komite etika lapaʻau Spanish a me Denemaka Comité de Ética de la Investigación con medicamentos (CEIm) a me National Videnskabsetisk Komité (NVK) a me nā luna kūpono ʻo Agencia Espańola de Medicamentos y Productos Sanitarios (AEMPS) a me ka Danish. Keʻena Lapaʻau. Ua ʻae kēia mau mana i ka hoʻohui ʻana o ka Phase II/III. Hiki i kēia ke ala wikiwiki i ka mākeke ma muli o ka mālama ʻana i ka manawa a me ka hoʻemi ʻana o nā mea maʻi e pono ai e aʻo.

Ua hoʻopau ʻo Neuroplast CEO, Johannes de Munter: "ʻO ka hoʻomaka ʻana o kēia hoʻokolokolo Phase II e hōʻailona i kahi mea nui i kā mākou misionari e hoʻihoʻi i ka ʻike i ka poʻe i loaʻa i nā maʻi neurodegenerative no ka loaʻa ʻole o nā lāʻau lapaʻau kūpono."

Ua loaʻa iā Neuroplast ke kālā kūpono no ke ala e loaʻa ai ka ʻae ʻana o ka mākeke EMA no ka mālama ʻana iā TSCI. Ke ʻimi nei ka hui i kālā hou no nā ʻāina ʻē aʻe, a e ʻimi i ka hiki ke ākea o ka ʻenehana ʻenehana Neuro-Cells® no ka Traumatic Brain Injury a me Frontotemporal Dementia.