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

Phase 1Not Yet RecruitingNCT06638970

Baermed54 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy Drugs Resistant Epilepsy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Changes frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections

Patients achieved a response if there are changes in frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections.Best outcome when the frequency and duration of the seizures less frequent, worst outcome when the frequency and duration of the seizures get more frequent