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.
He aha e lawe ʻia mai kēia ʻatikala:
- Antonio Oliviero, MD, PhD, Principal Investigator at Hospital Nacional de Parapléjicos de Toledo, Spain, states, “After having worked in the field of Spinal Cord Injury for almost twenty years, I am happy to contribute to establishing the role of cell transplantation in the functional recovery of individuals with Spinal Cord Injury.
- With the aim of giving back perspective to people that suffer from neurodegenerative diseases, Neuroplast developed Neuro-Cells®, a treatment that uses the patients own stem cells to prevent (further) loss of function during the acute phase after sustaining damage to the spinal cord, to preserve function, mobility and independence.
- The trial is conducted under official approval from the Spanish and Danish medical ethical committees Comité de Ética de la Investigación con medicamentos (CEIm) and National Videnskabsetisk Komité (NVK) and the competent authorities Agencia Espańola de Medicamentos y Productos Sanitarios (AEMPS) and the Danish Medicines Agency.
