I-Neuroplast ibhalise isiguli sayo sokuqala ocwaningweni lomtholampilo lweSigaba II ukuze ihlole ukusebenza kokwelashwa kwayo okuguquguqukayo kwe-Neuro-Cells® okuhloswe ngayo ukuvimbela umonakalo owengeziwe ohlelweni lwezinzwa olumaphakathi ngemva kokusekela i-acute Traumatic Spinal Cord Injury (TSCI). Icala lenziwa ngokubambisana neSibhedlela i-Nacional de Parapléjicos e-Toledo, eSpain. Muva nje, i-Neuroplast imemezele imiphumela emihle yeSigaba I nge-Neuro-Cells® yokwelashwa kwe-TSCI futhi yaphinde yathola u-€10 million (US$11.5M) ukuze uthole indlela yokuthola imvume yemakethe ye-EMA enemibandela.
Ngonyaka, cishe abantu abangu-29,000 kulo lonke elaseYurophu nase-USA bahlushwa i-TSCI eyingozi, ukwelashwa okusebenzayo okungatholakali okwamanje. Iziguli zivame ukuba nokukhubazeka impilo yonke kanye nokuncika, okunomthelela omubi eqophelweni lempilo. Ngaphezu kwalokho, izindleko ezihlobene nomphakathi wonkana zilinganiselwa ngaphezu kwezigidigidi ezingama-€11.4 (amaRandi ayizigidi eziyizinkulungwane ezingu-13) ngonyaka.
Ngenhloso yokubuyisela umbono kubantu abahlushwa izifo ze-neurodeergenerative, i-Neuroplast yakha i-Neuro-Cells®, ukwelashwa okusebenzisa iziguli ama-stem cells ukuvimbela (okuqhubekayo) ukulahlekelwa umsebenzi ngesikhathi sesigaba esibucayi ngemva kokulimala komgogodla. , ukulondoloza ukusebenza, ukuhamba nokuzimela. Inhlanganisela enjalo a) ukwelashwa okuzenzakalelayo kanye b) nokusetshenziswa kwe-intrathecal ku-c) ukulungiselelwa okunamandla yikhona okwenza i-Neuro-Cells® ihluke.
Ucwaningo lwamazwe ngamazwe oluphakathi nendawo, olulawulwa yi-placebo
Ukuhlolwa komtholampilo kweSigaba sesi-II kwenziwa uMphenyi Omkhulu u-Antonio Oliviero, MD, PHD kanye noProf. Jörg Mey waseSibhedlela iParapléjicos eToledo, eSpain.
Ucwaningo luwuhlolo olungahleliwe nolulawulwa yi-placebo, olunomklamo ongenelela ngaphambi kwesikhathi nangemuva kwesikhathi. Iqembu lokungenelela lithola i-Neuro-Cells® esigabeni se-sub-acute ngemva kokugcina ukuhlukumezeka, ngokulandelwa kwezinyanga eziyisithupha kuze kube sekugcineni kwabo okuyinhloko. Iqembu le-placebo lizothola i-placebo ekuqaleni, kodwa lizophathwa nge-Neuro-Cells® ngemva kwesikhathi sokuqala sokulandelela esiyizinyanga eziyisithupha. Ukulandelela okunezinhlangothi eziningi kuwo womabili amaqembu kuhlanganisa izilinganiso zomphumela ezimisiwe neziqinisekisiwe ekusebenzeni kwezimoto nezinzwa kanye nezilinganiso zegazi eziningi kanye ne-cerebrospinal fluid.
U-Antonio Oliviero, MD, PhD, Umphenyi Oyinhloko esibhedlela i-Nacional de Parapléjicos de Toledo, eSpain, uthi, "Ngemva kokusebenza emkhakheni we-Spinal Cord Injury cishe iminyaka engamashumi amabili, ngiyajabula ukufaka isandla ekusunguleni indima yokufakelwa kweseli ukululama kokusebenza kwabantu abane-Spinal Cord Injury. Ngijabule ngokuba yingxenye yalesi sinyathelo esisha socwaningo, kanye neNeuroplast.”
Lolu cwaningo luzobandakanya iziguli eziyi-16 ezizofakwa emasontweni ayisithupha kuya kwayisishiyagalombili ngemuva kokulimala komgogodla.
Icala liqhutshwa ngaphansi kwemvume esemthethweni evela ekomidini lezempilo laseSpain nelaseDanish Comité de Ética de la Investigación con medicamentos (CEIm) kanye ne-National Videnskabsetisk Komité (NVK) kanye neziphathimandla ezinekhono i-Agencia Espańola de Medicamentos y Productos Sanitarios (AEMPS) kanye ne-Danish Sanitarios (AEMPS) I-Ejensi Yemithi. Lezi ziphathimandla zagunyaza indlela ehlanganisiwe yeSigaba II/III. Lokhu kwenza indlela esheshayo ebheke emakethe ngenxa yokonga ngesikhathi kanye nenani elincishisiwe leziguli ezidingekayo ukuze zifunde.
Isikhulu esiphezulu seNeuroplast, uJohannes de Munter, siphetha ngokuthi: “Ukuqala kwalolu cwaningo lweSigaba II kuphawula enye ingqopha-mlando emkhankasweni wethu wokubuyisela umbono kubantu abahlushwa izifo ze-neurodegenerative ezingenazo izindlela zokwelapha ezisebenzayo.”
I-Neuroplast ithole uxhaso olwanele lwendlela yokuthola imvume yemakethe ye-EMA enemibandela yokwelashwa kwe-TSCI. Inkampani ifuna ukuxhaswa okwengeziwe kwezinye izindawo, kanye nokuhlola amandla abanzi enkundla yobuchwepheshe ye-Neuro-Cells® ye-Traumatic Brain Injury kanye ne-Frontotemporal Dementia.
