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NOT YET RECRUITING
NCT06638970
PHASE1

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

Sponsor: Baermed

View on ClinicalTrials.gov

Summary

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?

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-12-01

Completion Date

2026-10-31

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

DRUG

Secretome

3 ml Injection of secretome for 4 times two weeks apart

Locations (1)

Main Clinic Prof. Dadang Hawari

Jakarta, DKI Jakarta, Indonesia