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

NCT06638970 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-10-15

No results posted yet for this study

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?

Conditions

Interventions

DRUG

Secretome

3 ml Injection of secretome for 4 times two weeks apart

Sponsors & Collaborators

  • Tarumanagara University

    collaborator OTHER

  • Baermed

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-10-31
Completion
2026-10-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638970 on ClinicalTrials.gov