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

October 10, 2024 updated by: Baermed

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Siufui Hendrawan, M.D., Ph.D.
  • Phone Number: +41 387 30 70

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 12810
        • Main Clinic Prof. Dadang Hawari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secretome Injection
patient will receive 4 times secretome injection every two weeks for two months
Drug: Secretome
3 ml Injection of secretome for 4 times two weeks apart
No Intervention: Best Treatment Practice
patient will receive standart therapy for four months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
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
From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
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
From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
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
From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baermed

Collaborators

Tarumanagara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

October 6, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-UTHREC/UNTAR/I/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Case Report Form (all collected IPD)

IPD Sharing Time Frame

After publication with no end date

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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