The Unmet Need
In April 2018, the Centers for Disease Control announced that autism affects 1 in 59 individuals under 21 living in the U.S. That’s a 15% increase in prevalence from the previous rate of 1 in 68. ASD is diagnosed by subjective psychological behavioral tests including ADOS (Autism Diagnostic Observation Schedule) conducted by neurologists, psychologists and psychiatrists. Since these tests assess communication, they cannot be performed on young infants. There is no objective quantitative test for ASD. There are no FDA-approved treatments for the core symptoms of ASD. Annual expenses for children with ASD are more than 7 times the expenses for typically developing children. Costs of lifelong care for ASD in the US have been estimated at $2.4M per patient.
Cell-El’s Diagnostic and Therapeutic Innovation
The causes of ASD remain unknown. Preliminary results from our diagnostic study provide evidence for the association between immune dysfunction and ASD. Cell-El is studying stem cell therapy (SCT) prior to and after treatment in an attempt to restore normal immune function as part of a comprehensive study to monitor immune markers.
There is an urgent need to objectively diagnose ASD at a very early age, given that starting treatment for ASD early in life is believed to improve long-term outcomes. Cell-El has investigated blood samples collected from over 150 children and found promising preliminary indications of the role of the immune system in ASD. This study is actively recruiting ASD children to confirm our preliminary findings.
Diagnostic Academic Work: Cell-El published a review in the Journal of Autoimmunity (2013) on the epidemiological, serological, and epigenetic evidence for the relationship between the immune system and many cases of ASD, as well our paper in FRONTIERS.
Therapeutic Academic Work: Cell-El published in Medical Hypotheses on the therapeutic properties of MSCs for ASD (2015). Cell-El has been invited as guest editors to Frontiers (Nature group) to publish a special volume on ASD – Searching for the biological basis and behavioral symptoms and new therapeutic targets.
Ongoing Diagnostic Clinical Trial
Cell-El received Ethics Committee approval for a multi-center clinical trial in Israel, Canada and Switzerland, aiming to test blood as well as urine and stool of ASD children for biomarkers. Cell-El has already collected samples from over 150 children with ASD and a control group of typically developed children
Planned Therapeutic Clinical Trial: Cell-El is planning a clinical trial in which children with severe ASD will undergo SCT, accompanied by psychological and laboratory evaluations to assess the impact of the treatment on autistic behavior, the immune system and the potential correlation between them.
If you are interested in finding out more about our diagnostic study, please contact us.
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