La ELA o ALS (esclerosis lateral amiotrófica) es una disfunción neuro-degenerativa que progresa rápidamente y es mortal en los nervios motores superiores e inferiores que controlan la función muscular.
La compañía israelí Kadimastem dice que espera estar pronto en conversaciones con la Administración de Alimentos y Medicamentos para avanzar con las células AstroRx de la compañía, después de demostrar resultados prometedores con la cohorte A de su ensayo clínico de fase 1 / 2a para el tratamiento de pacientes con esclerosis lateral amiotrófica
«Planeamos tener discusiones este año para obtener claridad regulatoria sobre los próximos pasos de nuestro ensayo y con la esperanza de que los resultados de este estudio respalden el avance al próximo ensayo clínico multicéntrico», dijo Hadas ( Dasy) Mandel, director de desarrollo de negocios de Kadimastem.
AstroRx de Kadimastem tiene la capacidad de reemplazar el funcionamiento de las células dañadas utilizando células madre alogénicas (disponibles en el mercado).
«Si bien las células no pueden reemplazar directamente las neuronas motoras enfermas, las células madre pueden diferenciarse en células que apoyan el sistema nervioso central, como los astrocitos», explica un comunicado de la compañía. Los astrocitos, también conocidos como células de soporte del sistema nervioso, secretan factores neurotróficos y eliminan las sustancias tóxicas que rodean las neuronas que funcionan mal, proporcionando así neuroprotección que puede retrasar la degeneración de las neuronas motoras.
La cohorte A de su ensayo clínico de fase 1 / 2a incluyó cinco pacientes, cada uno tratado con una dosis de 100×10 de células AstroRx desarrolladas por la compañía y que luego completaron los seis meses de seguimiento posterior al tratamiento. El CEO de la compañía, Rami Epstein, dijo que, después de verificar la progresión de la enfermedad en pacientes antes y después del ensayo de acuerdo con la Escala de calificación funcional de ALS revisada (ALSFRS-R), el criterio estándar de oro para evaluar la progresión de ALS, los resultados mostraron que «nuestro tratamiento es eficaz ”para apoyar el mal funcionamiento de las células en el cerebro y la médula espinal, a fin de retrasar la progresión de la enfermedad y mejorar la calidad de vida y la esperanza de vida de los pacientes.
Durante el programa de pre tratamiento de tres meses, la función muscular del paciente disminuyó a una tasa promedio de -0.87 por mes, según la escala ALSFRS-R, una tasa similar a la reportada en la literatura científica.
En contraste positivo, el cambio promedio de ALSFRS-R en los tres meses posteriores al tratamiento fue de +0.26 por mes.
«Estos resultados demuestran una diferencia estadísticamente significativa entre la pendiente en el período previo al tratamiento y la pendiente en el período de tres meses posterior al tratamiento», dijo Epstein.
Del mismo modo, se observaron mejoras en el cuarto mes del período posterior al tratamiento, aunque no en los meses cinco y seis. Epstein dijo que esto indica que una dosis más alta y / o administraciones repetidas pueden lograr una eficacia prolongada, las cuales se evaluarán en los próximos meses entre las cohortes B y C de este ensayo clínico.
Además, no se informaron eventos adversos graves relacionados con el tratamiento o toxicidades limitantes de la dosis durante los seis meses posteriores al período de seguimiento de la cohorte A.
El experimento se lleva a cabo en el Centro Médico Hadassah en Jerusalén. Kadimastem tiene su sede en Ness Ziona.
Un comunicado compartido por la compañía describió los síntomas de la enfermedad como debilidad muscular, pérdida de la función motora, parálisis, problemas respiratorios y eventualmente la muerte.
Según Epstein, la mayoría de las personas diagnosticadas con ELA viven solo hasta cinco años desde el momento del diagnóstico. Según el Instituto de Desarrollo de Terapia ALS, hay aproximadamente 450,000 pacientes con ELA en todo el mundo.
Específicamente, AstroRx es un producto de terapia celular que contiene astrocitos funcionales sanos derivados de células madre embrionarias humanas que tienen como objetivo proteger las neuronas motoras enfermas. Las células se inyectan en el paciente a través del canal espinal.
La compañía inició sus primeros ensayos clínicos de ELA en marzo de 2018.
El profesor Michel Revel, fundador y CEO de la compañía y ganador tanto del Premio EMET como del Premio Israel, dijo que los resultados de los ensayos clínicos «brindan la confianza necesaria para avanzar» con las cohortes B y C, y dijo que ambos «sostienen el potencial para una respuesta prolongada «.
La cohorte B involucra pacientes que toman una dosis más alta; C implica tratamientos repetidos.
Revel agregó que el perfil de seguridad positivo del tratamiento también permitirá a la compañía probar AstroRx en otras enfermedades neurodegenerativas.
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