Stem cells against amyotrophic lateral sclerosis
The phase I clinical trial of the therapy of amyotrophic lateral sclerosis or Charcot's disease, a hereditary neurodegenerative disease that leads to muscle atrophy and ultimately death of patients as a result of respiratory arrest, which lasted about two years, demonstrated the safety and good tolerability of injecting nerve stem cells into the gray matter of the spinal cord of patients in doses up to 100,000 cells. A total of 15 patients participated in this phase of the study. At the beginning of the study, five injections of 100,000 cells were administered to the patient, after which the number of injections administered to one patient was increased to 15. The results of the examination of patients who underwent experimental therapy indicate the possibility of stopping the progression of the disease in one of the subgroups of participants.
On April 17, Neuralstem, a licensed therapeutic product under test, announced that the U.S. Food and Drug Administration (FDA) has approved a Phase II clinical trial. As part of this study, the study of the safety of therapy will continue, and its main goal is to determine the maximum tolerated dose of cells injected into the gray matter of the spinal cord by a previously tested method. Any manifestations indicating that cell therapy may have an effect on the symptoms or course of the disease will also be evaluated.
The study is planned to involve 15 patients divided into 5 cohorts, differing in the dosage of injected cells. The first 12 patients will be injected into the cervical spinal cord, where the implanted cells will be able to maintain respiratory function. The last three patients will have cells injected into the cervical and lumbar spinal cord. The maximum number of injections administered to one patient will be 40, while the dosage of cells in one injection will gradually increase to 400,000 cells based on the results of a safety assessment.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru Based on the materials of the University of Michigan: FDA approves Phase II of stem cell trial for ALS led by U-M's Dr. Eva Feldman and Neuralstem: Neuralstem Receives FDA Approval To Comment Phase II Stem Cell Trial In Amytrophic Lateral Sclerosis.
Portal "Eternal youth" http://vechnayamolodost.ru19.04.2013