NCT03676569: EPIMSC

Intrathecal Autologous ADRC Treatment of Autoimmune Refractory Epilepsy

Completed Phase 1 Last updated 15 April 2020

What this trial tests

Phase 1 trial testing ADRC transplantation in autoimmune refractory epilepsy in Refractory Epilepsy in 6 participants. Completed in 14 April 2019.

Timeline

15 November 2015

Primary endpoint
14 April 2019

14 April 2019

Quick facts

Lead sponsor	Mossakowski Medical Research Centre Polish Academy of Sciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	15 November 2015
Primary completion	14 April 2019
Estimated completion	14 April 2019

Drugs / interventions tested

• ADRC transplantation in autoimmune refractory epilepsy — full drug profile →

Conditions studied

• Refractory Epilepsy — all drugs for Refractory Epilepsy →

Sponsor

Mossakowski Medical Research Centre Polish Academy of Sciences — full company profile →

Who can join

Eligibility, any sex, with Refractory Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Trials Based on Mesenchymal Stromal Cells are Exponentially Increasing: Where are We in Recent Years?
   Galderisi U, Peluso G, Di Bernardo G. · · 2022 · cited 175× · PMID 34398443 · DOI 10.1007/s12015-021-10231-w
2. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
3. Gene and Cell Therapy for Epilepsy: A Mini Review.
   Shaimardanova AA, Chulpanova DS, Mullagulova AI, Afawi Z, et al · · 2022 · cited 22× · PMID 35645733 · DOI 10.3389/fnmol.2022.868531
4. Epilepsy Characteristics in Neurodevelopmental Disorders: Research from Patient Cohorts and Animal Models Focusing on Autism Spectrum Disorder.
   Chakraborty S, Parayil R, Mishra S, Nongthomba U, et al · · 2022 · cited 18× · PMID 36142719 · DOI 10.3390/ijms231810807
5. Intrathecal Infusion of Autologous Adipose-Derived Regenerative Cells in Autoimmune Refractory Epilepsy: Evaluation of Safety and Efficacy.
   Szczepanik E, Mierzewska H, Antczak-Marach D, Figiel-Dabrowska A, et al · · 2020 · cited 18× · PMID 32190059 · DOI 10.1155/2020/7104243
6. Autologous olfactory mucosa mesenchymal stem cells treatment improves the neural network in chronic refractory epilepsy.
   Liu ZZ, Huang Y, Hong CG, Wang X, et al · · 2023 · cited 13× · PMID 37674249 · DOI 10.1186/s13287-023-03458-6
7. Stem cell repair strategies for epilepsy.
   Ma X, Wang Z, Niu Y, Zhao J, et al · · 2026 · cited 3× · PMID 40537022 · DOI 10.4103/nrr.nrr-d-24-01337
8. Rewiring the seizing brain: stem cell grafts as neuromodulatory architects in epilepsy therapy.
   Wang Z, Ma Y, Hu X, Xia Y. · · 2025 · cited 1× · PMID 40917677 · DOI 10.3389/fneur.2025.1596484