Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06638970

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Drugs Resistant Epilepsy Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Main Clinic Prof. Dadang Hawari

Jakarta, DKI Jakarta, 12810, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secretome

Drug

3 ml Injection of secretome for 4 times two weeks apart

Primary outcomes

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

    Time frame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

    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

  2. Changes in EEG and qEEG (Alpha,Beta, Delta, and Theta wave) results of drugs resistant epilepsy after two months secretome injections

    Time frame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

    Patients achieved a response if there are changes in EEG and qEEG (Alpha,Beta, Delta, and Theta wave) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the EEG and qEEG (Alpha,Beta, Delta, and Theta wave) get a better results, worst outcome when EEG and qEEG (Alpha,Beta, Delta, and Theta wave) get a worse results

Secondary outcomes

  1. Changes in Mini Mental State Examination (MMSE) results of drugs resistant epilepsy after two months secretome injections

    Time frame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

    Patients achieved a response if there are changes in Mini Mental State Examination (MMSE) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the Mini Mental State Examination (MMSE) get a increase results, worst outcome when Mini Mental State Examination (MMSE) get a decrease results

  2. Changes in Perceived Stress Scale (PSS) results of drugs resistant epilepsy after two months secretome injections

    Time frame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

    Patients achieved a response if there are changes in Perceived Stress Scale (PSS) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the Perceived Stress Scale (PSS) get a increase results, worst outcome when Perceived Stress Scale (PSS) get a decrease results

  3. Changes in Gait Deviation Index (GDI) results of drugs resistant epilepsy after two months secretome injections

    Time frame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

    Patients achieved a response if there are changes in Gait Deviation Index (GDI) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the Gait Deviation Index (GDI) get a increase results, worst outcome when Gait Deviation Index (GDI) get a decrease results

Other outcomes

  1. Changes in Quality of The Life in Epilepsy Inventory (QOLIE-31) results of drugs resistant epilepsy after two months secretome injections

    Time frame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

    Patients achieved a response if there are changes in Quality of The Life in Epilepsy Inventory (QOLIE-31) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the Quality of The Life in Epilepsy Inventory (QOLIE-31) get a increase results, worst outcome when Quality of The Life in Epilepsy Inventory (QOLIE-31) get a decrease results

Study contacts

Contact information is provided by the study sponsor or research team.

Hans Ulrich Baer, Prof. Dr. med

CONTACT

[email protected]

628156963254

Siufui Hendrawan, M.D., Ph.D.

CONTACT

+41 387 30 70

Sponsors and collaborators

Lead sponsor

Baermed

Other

Collaborators

  • Tarumanagara University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.