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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBaermed

About this trial

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?

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Secretome

Treatment groups

54 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Baermed

Lead sponsor

Tarumanagara University

Collaborator