Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04530318
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2020-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis
Sponsor:
Judit Pich
Organization:
Study Overview
Official Title:
Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TolDecCOMBINEM
Brief Summary:
The aim of this project is to assess properly the clinical efficacy of TolDec therapy by imaging, clinical and surrogate end-points related with the activity of the disease.
Detailed Description:
Our working hypothesis is to make a combination therapy with low-moderate efficacy immunomodulatory drugs with the aim of increasing efficacy without causing serious adverse effects such as those associated with the available high-efficacy therapies. Cellular therapies represent a highly specific treatment aimed to target selective "pathogenic" cells subsets. Tol-Dec loaded with immunogenic peptides interacts with Ag-specific T lymphocytes inducing regulatory T cells without affecting other cell subsets leading to a antinflammatory shift of immunological responses.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-000737-41 | EUDRACT_NUMBER | None | View |