drugset / Trial / NCT03280056

Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients

NCT03280056 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are enriched from the patient's own bone marrow, propagated ex vivo and induced to secrete Neurotrophic factors (NTFs). The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally by standard lumbar puncture where neurons and glial cells are expected to take up the neurotrophic factors secreted by the transplanted cells

Timeline

Start
2017-08-28
Primary completion
2020-09-29
Completion
2020-09-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator NurOwn Cell therapy 1e+08 cells Intrathecal
Comparator NurOwn Cell therapy 1.25e+08 cells Intrathecal