NCT06638970

Brief 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. 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. 2.How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group?
  3. 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. 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. 5.How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group?
  6. 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?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
6mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Dec 2024Oct 2026

First Submitted

Initial submission to the registry

October 6, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

October 15, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

October 6, 2024

Last Update Submit

October 10, 2024

Conditions

EpilepsyDrugs Resistant Epilepsy

Keywords

secretomestem cellsepilepsydrug resistant epilepsyqEEG

Outcome Measures

Primary Outcomes (2)

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

    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

    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 Outcomes (3)

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

    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

    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

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

Other Outcomes (1)

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

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

Study Arms (2)

Secretome Injection

EXPERIMENTAL

patient will receive 4 times secretome injection every two weeks for two months

Drug: Secretome

Best Treatment Practice

NO INTERVENTION

patient will receive standart therapy for four months

Interventions

SecretomeDRUG

3 ml Injection of secretome for 4 times two weeks apart

Secretome Injection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Main Clinic Prof. Dadang Hawari

Jakarta, DKI Jakarta, 12810, Indonesia

Location

Related Links

MeSH Terms

Conditions

EpilepsyDrug Resistant Epilepsy

Interventions

Secretome

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MetabolomeMetabolism

Central Study Contacts

Hans Ulrich Baer, Prof. Dr. med

CONTACT

628156963254hans.baer@baermed.ch

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

CONTACT

+41 387 30 70

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2024

First Posted

October 15, 2024

Study Start

December 1, 2024

Primary Completion

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Last Updated

October 15, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Case Report Form (all collected IPD)

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
After publication with no end date

Locations

ID(1)