Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638970
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief 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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None