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A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)

General Information
Summary 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.
Clinical trials phase Phases 1/2
Start date (estimated) 2018-04-12
End date (estimated) 2020-06-22
Clinical feature
Label amyotrophic lateral sclerosis
Link http://purl.obolibrary.org/obo/DOID_332
Description A motor neuron disease that is characterized by muscle spasticity, rapidly progressive weakness due to muscle atrophy, difficulty in speaking, swallowing, and breathing.
Publications

Administrative Information
NCT number NCT03482050
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03482050
Other study identifiers
Name ASTRO-001-IL
Source weblink https://clinicaltrials.gov/ct2/show/NCT03482050
Study sites
Public contact
Email HCRC_ALS@hadassah.org.il
Public email HCRC_ALS@hadassah.org.il
First name Chen
Last name G.
Phone +972-2-6779372
Country
Israel
Sponsors Kadimastem

Cells
Source pluripotent stem cell lines
Which differentiated cell type is used
Label astrocyte
Link http://purl.obolibrary.org/obo/CL_0000127
Description A class of large neuroglial (macroglial) cells in the central nervous system - the largest and most numerous neuroglial cells in the brain and spinal cord. Astrocytes (from 'star' cells) are irregularly shaped with many long processes, including those with 'end feet' which form the glial (limiting) membrane and directly and indirectly contribute to the blood-brain barrier. They regulate the extracellular ionic and chemical environment, and 'reactive astrocytes' (along with microglia) respond to injury.; Astrocytes are reportedly CD68-negative, CD121a-positive, CD184-positive, CD192-positive, CRF-positive, EGFR-positive, GFAP-positive, GLUT1-positive, MBP-negative, and NGFR-positive.

Recruitment
Recruitment Status Completed
Estimated number of participants 16
Contact institutions/departments