Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety of Autologous MSC Infusion to Treat Epilepsy (AMSCDRSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02497443
Recruitment Status : Active, not recruiting
First Posted : July 14, 2015
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ministry of Public Health, Republic of Belarus

Brief Summary:
• The goal of this study was to evaluate the safety and efficacy of autologous MSC application for the therapy of drug-resistant symptomatic epilepsy. Adult (18-60 years old) patients (pts) of both sexes suffering from refractory epilepsy with frequent (>5 events per month) seizures were included in this study. The pts were randomized to the standard treatment with anti-epileptic drugs (control group, 30 pts) or anti-epileptic drugs plus autologous mesenchymal stem cells (MSCs) (study group, 30 pts). The pts in the study group received one intravenous injection of ex vivo expanded MSCs (40-101 x 106 cells) and one subsequent endolumbal injection of neuroinduced MSCs (2.7 - 8.0 x 106 cells). Both the unfavorable reactions to MSC infusions and the clinical effects, including complications, were examined. The unfavorable reactions to the MSC injections included local pain or hemorrhage at the site of injection and systemic reactions of the central nervous system (CNS; i.e., hyperthermia, fatigue, and myalgia).The possible beneficial effects of therapy in the two groups of pts were examined based on clinical observations and electroencephalography measurements (prior and 12 months after the application of the MSC-based therapy). To determine potential changes in disease progression, the signs of cognitive impairment, behavioral disorders, and particularly, changes in seizure character and frequency were evaluated using the National Hospital Scale of Seizure Severity. The main points of disease monitoring were "yes" or "no" responses (to therapy), seizure frequency (per month), and remission of disease. Electroencephalography (EEG) recordings were performed to evaluate electrical alpha, beta, theta and delta waves based on standard and additional criteria. The paroxismality index, the peak frequency of EEG activity, the index of slow activity, and the summarized points of EEG pathology signs were calculated for each patient. All assessments were performed for the pts in the control and study groups, and the obtained data were compared to identify the potential differences between the two pts groups. Therapy was terminated when immediate unfavorable reactions to the MSC injections were observed. The final observation of each patient included clinical and EEG assessments at the time point of 12 months (or more) after the application of the MSC-based therapy.

Condition or disease Intervention/treatment Phase
Epilepsy Biological: Autologous mesenchymal stem cells Phase 1 Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Masking was specified as Opel Label study in old format
Primary Purpose: Treatment
Official Title: Phase 1 Study of Autologous Mesenchymal Stem Cell Application for Therapy of Drug-Resistant Symptomatic Epilepsy
Study Start Date : April 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: study group
Pts undergoing carbamazepine, valproic acid, topiramate, lamotrigine, or phenobarbital (i.e.anti-epileptic drugs [AEDs]) and receiving autologous mesenchymal stem cells
Biological: Autologous mesenchymal stem cells
Autologous bone marrow-derived mesenchymal stem cells, expanded ex vivo and neuroinduced (a portion of the cells). The final autologous cultured MSCs (0.7 -1.4 x 106 cells/kg of weigh) and autologous neuroinduced MSCs (0.04 - 0.1 x 106 cells/kg of weigh) were used for intravenous administration (cultured MSCs) and a subsequent endolumbal injection (neuroinduced MSCs) one week later in the patients in an autologous manner.

No Intervention: control group
Pts undergoing carbamazepine, valproic acid, topiramate, lamotrigine, or phenobarbital (i.e.AEDs)



Primary Outcome Measures :
  1. Safety of autologous bone marrow-derived Mesenchymal Stem Cells in patients with Drug-Resistant Symptomatic Epilepsy [ Time Frame: 360 days ]
    • vital signs
    • adverse events related to infusion
    • physical examination indexes


Secondary Outcome Measures :
  1. Efficacy of autologous bone marrow-derived Mesenchymal Stem Cells in patients with Drug-Resistant Symptomatic Epilepsy [ Time Frame: 360 days ]
    • Complete (remission), partial response (>50% reduction of seizure) rate at 90 and 360 days
    • Complete response(CR)rate (%)=(number of CR/number of participants)*100%
    • Partial response(PR)rate (%)=(number of PR/number of participants)*100%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of symptomatic epilepsy,
  • Disease progression for the last 1-3 years,
  • Resistance of epilepsy to therapy with carbamazepine, valproic acid, topiramate, lamotrigine, and phenobarbital (anti-epileptic drugs/AEDs) as monotherapies or combination therapies;
  • Signed informed consent

Exclusion Criteria:

  • Central nervous system inflammatory disorders (meningoencephalitis of viral or parasite origin),
  • Chronic decompensated psychoses ,dementia, social disadaptation,
  • Central nervous system tumours.
  • Blood positivity for hepatitis B or C or HIV infection;
  • According to the judgment of the researchers, subjects who were unable to complete the study or may not have been able to comply with the requirements of this study (due to administrative or other reasons).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497443


Sponsors and Collaborators
Ministry of Public Health, Republic of Belarus
Investigators
Layout table for investigator information
Principal Investigator: Tatiana V Dakukina, MD,PhD Deputy Director for Research, Republican Scientific and Practical Center for Mental Health, Minsk, Belarus

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ministry of Public Health, Republic of Belarus
ClinicalTrials.gov Identifier: NCT02497443     History of Changes
Other Study ID Numbers: Minsk-MH001
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ministry of Public Health, Republic of Belarus:
drug-resistant symptomatic epilepsy
seizure
autologous mesenchymal stem cells
safety
remission
electroencephalography
refractory symptomatic epilepsy
autologous MSC
efficacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases