EpilepsyPhase 1NCT06638970
Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Drug Resistant Epilepsy Single Center, Non-randomized, Phase I Clinical Trial
A Phase 1 study testing Secretome in people with Epilepsy and Drugs Resistant Epilepsy, run by Baermed at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy, Drugs Resistant Epilepsy
- What is being tested?
- Secretome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2024to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Siufui Hendrawan, M.D., Ph.D. contact
About this study
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:
- 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?
- How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group?
- 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?
- 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?
- How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group?
- 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?
- Conditions
- Epilepsy, Drugs Resistant Epilepsy
- Being tested
- Secretome
- Keywords
- secretome, stem cells, epilepsy, drug resistant epilepsy, qEEG
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretomeDrug
3 ml Injection of secretome for 4 times two weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Secretome Injection | Experimental | patient will receive 4 times secretome injection every two weeks for two months Receives: Drug: Secretome |
| Best Treatment Practice | No intervention | patient will receive standart therapy for four months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baermed
- Sponsor type
- University, hospital or other
- Collaborators
- Tarumanagara University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638970
- Sponsor's protocol ID
- 001-UTHREC/UNTAR/I/2024
- Status last verified
- Sep 2024
- First submitted
- 6 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Case Report Form (all collected IPD)
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06638970
- Acronym / sponsor ID
- 001-UTHREC/UNTAR/I/2024
- Conditions
- Epilepsy, Drugs Resistant Epilepsy
- Keywords
- secretome, stem cells, epilepsy, drug resistant epilepsy, qEEG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- BaermedUniversity, hospital or other
- Collaborators
- Tarumanagara University
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group?
- 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?
- 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?
- How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secretome Injection | Experimental | Drug: Secretomepatient will receive 4 times secretome injection every two weeks for two months |
| Best Treatment Practice | No intervention | –patient will receive standart therapy for four months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secretome3 ml Injection of secretome for 4 times two weeks apart | Drug | Secretome Injection |
Primary outcome
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
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Case Report Form (all collected IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siufui Hendrawan, M.D., Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Secretome in people with Epilepsy and Drugs Resistant Epilepsy, run by Baermed at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Ulrich Baer, Prof. Dr. med (628156963254, hans.baer@baermed.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.