Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Drug Resistant Epilepsy Single Center, Non-randomized, Phase I Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-10-31

Brief Summary

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The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with epilepsy. The main questions it ams to answer are:

1. How is the relationship between secretome therapy and the reduction in seizure frequency and duration in patients with drug-resistant epilepsy in the adult age group?
2. How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group?
3. How is the relationship between secretome therapy and the Mini Mental State Examination (MMSE) score in patients with drug-resistant epilepsy in the adult age group?
4. How does secretome therapy affect stress levels as measured by the Perceived Stress Scale (PSS) in patients with drug-resistant epilepsy in the adult age group?
5. How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group?
6. How does secretome therapy affect quality of life as measured by the Quality of Life in Epilepsy Inventory (QOLIE-31) in patients with drug-resistant epilepsy in the adult age group?

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Detailed Description

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Conditions

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Epilepsy Drugs Resistant Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Secretome Injection

patient will receive 4 times secretome injection every two weeks for two months

Group Type EXPERIMENTAL

Secretome

Intervention Type DRUG

3 ml Injection of secretome for 4 times two weeks apart

Best Treatment Practice

patient will receive standart therapy for four months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Secretome

3 ml Injection of secretome for 4 times two weeks apart

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 18 to 60 years.
* Individuals with a clinical diagnosis of epilepsy confirmed by a neurologist based on internationally accepted criteria.
* Individuals with a seizure frequency of at least 6 times in 12 months.
* Individuals who have a history of recurrent seizures that are not controlled with standard antiepileptic treatment of at least 2 types of drugs for at least 12 months.
* Individuals who are in stable general health, without life-threatening acute illnesses or uncontrolled medical conditions.
* Individuals who do not have a history of other neurodegenerative diseases or severe psychiatric disorders that could affect the results of the study.
* Individuals who are not pregnant or breastfeeding.
* Individuals who are willing to provide written consent after receiving complete information about the study.

Exclusion Criteria

* Individuals with a history of stroke or evidence of stroke on medical examination.
* Individuals who have undergone surgery for the treatment of epilepsy.
* Individuals with a history of allergy or hypersensitivity reactions to the secretome or related components.
* Individuals with active or uncontrolled autoimmune disease.
* Individuals receiving immunosuppressive therapy.
* Individuals with severe hepatic or renal impairment.
* Individuals with significant vascular or blood vessel disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No