drugset / Trial / NCT03676569

Intrathecal Autologous ADRC Treatment of Autoimmune Refractory Epilepsy

NCT03676569 ↗

NaSingle-groupOpen-labelTreatment

Summary

Refractory epilepsies caused by an autoimmune mechanisms lead in children to progressive neurodegeneration. Immunomodulation therapy is effective only in a half of such cases. New approaches are undertaken. It was found that ADRC (adipose derived regenerative cells) isolated from adipose tissue consist mesenchymal stem cells that act as tissue repair cells. The purpose of this experimental study is to evaluate the possibility and safety of the use of multipotent mesenchymal adipose derived regenerative cells (ADRC) in patients diagnosed with an autoimmune determined refractory epilepsy. Study protocol: Intrathecal infusions of autologous ADRC obtained after liposuction followed by isolation by Cytori system will be performed. Procedure will be repeated 3 times every 3 months in each patient. Neurological status, brain MRI, cognitive function and antiepileptic effect will be supervised during 24 months.

Timeline

Start
2015-11-15
Primary completion
2019-04-14
Completion
2019-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject adipose derived regenerative cells Cell therapy — Intrathecal

Indications