This is a study of transplantation of Astrocytes derived from human embryonic stem cells, in patients with Amyotrophic Lateral Sclerosis (ALS). There will be no change in the routine ALS treatment of the patients enrolled into the study. Treatment will be administered in addition to the appropriate standard of care treatment. The study hypothesis is that transplantation of Astrocyte(AstroRx) cells can compensate for the malfunctioning of patients' own astrocytes by restoring physiological capabilities like the reuptake of excessive glutamate, reducing oxidative stress, reducing other toxic compounds, as well as by secreting different neuroprotective factors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Astrocytes derived from human embryonic stem cells
Hadassah Ein Kerem Medical Center
Jerusalem, Israel
Number of participants with treatment emergent adverse events as assessed by CTCAE Version 4.03
Safety and tolerability assessment will be based on treatment emerged adverse events
Time frame: 11 Months
Change in the ALS functional rating scale
Preliminary efficacy assessment to measure response to treatment or progression of disease. Scale includes 12 questions related to tasks. Each task rated on a five-point scale from 0 = unable to do the task, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0 = worst and 48 = best.
Time frame: 11 Months
Change in predicted slow vital capacity (%SVC)
Preliminary efficacy assessment to measure respiratory muscle strength
Time frame: 11 Months
Change in muscle strength grading by JAMAR grip strength
Preliminary efficacy assessment to measure hand grip strength
Time frame: 11 Months
Change in muscle strength grading by hand held dynamometer (HHD)
Preliminary efficacy assessment to measure muscle strength in limb muscles
Time frame: 11 Months
Change in Quality of Life questionnaire (ALSAQ-40)
Preliminary efficacy assessment to measure the subjective well-being of patients
Time frame: 11 Months
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