Clinical trial 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
Official title: Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Drug Resistant Epilepsy Single Center, Non-randomized, Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Epilepsy
Drugs Resistant Epilepsy
Keywords: secretome
stem cells
epilepsy
drug resistant epilepsy
qEEG
Lead sponsor: Baermed
Sponsor class: OTHER
Collaborators: name: Tarumanagara University
First posted: 2024-10-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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?


Eligibility criteria: 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.

Primary outcomes:
measure: Changes frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections
timeFrame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
measure: Changes in EEG and qEEG (Alpha,Beta, Delta, and Theta wave) results of drugs resistant epilepsy after two months secretome injections
timeFrame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
Secondary outcomes:
measure: Changes in Mini Mental State Examination (MMSE) results of drugs resistant epilepsy after two months secretome injections
timeFrame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
measure: Changes in Perceived Stress Scale (PSS) results of drugs resistant epilepsy after two months secretome injections
timeFrame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
measure: Changes in Gait Deviation Index (GDI) results of drugs resistant epilepsy after two months secretome injections
timeFrame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
Other outcomes:
measure: Changes in Quality of The Life in Epilepsy Inventory (QOLIE-31) results of drugs resistant epilepsy after two months secretome injections
timeFrame: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
Locations:
city: Jakarta
country: Indonesia
facility: Main Clinic Prof. Dadang Hawari
state: DKI Jakarta
Study officials:
References: