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Intrathecal Autologous ADRC Treatment of Autoimmune Refractory Epilepsy

NCT03676569 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-04-15

No results posted yet for this study

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.

Conditions

  • Refractory Epilepsy

Interventions

BIOLOGICAL

ADRC transplantation in autoimmune refractory epilepsy

Sponsors & Collaborators

  • Institute of Mother and Child, Warsaw, Poland

    collaborator OTHER

  • Mossakowski Medical Research Centre Polish Academy of Sciences

    lead OTHER

Principal Investigators

  • Dorota Antczak-Marach, M.D. · Institute of Mother and Child

  • Ewa Sawicka, Prof. · Institute of Mother and Child

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03676569 on ClinicalTrials.gov