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

Baermed

Status and phase: Not yet enrolling; Phase 1

Conditions: Drugs Resistant Epilepsy; Epilepsy

Treatments: Drug: Secretome

Study type: Interventional

Funder types: Other

Identifiers

NCT06638970

001-UTHREC/UNTAR/I/2024

Details and patient eligibility

About

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?

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Secretome Injection

Experimental group

Description:

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

Treatment:

Drug: Secretome

Best Treatment Practice

No Intervention group

Description:

patient will receive standart therapy for four months