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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000737-41 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TolDec | Experimental | Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded |
|
| Placebo | Placebo Comparator | Placebo of dendritic cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded | Other | The infusion of the cells / placebo will take place at the Hospital Clínic de Barcelona (weeks 0, 2 and 4). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24). | week 12, 18 and 24 | |
| Proportion of patients with any Grade 3 -4 adverse events related to product administration during the study period. | week 24 | |
| Proportion of patients with any Grade 3 -4 adverse events related to study product. | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with any Grade 3 -4 adverse events related to study product. | week 24 | |
| Proportion of patients with any SAE events related to study product. | week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yolanda Blanco, MD | Hospital Clinic of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Moisés Broggi | L'Hospitalet de Llobregat | Barcelona | Spain | |||
| Hospital Universitari de Bellvitge |
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|
| Placebo | Other | The infusion of the cells / placebo will take place at the Hospital Clínic de Barcelona (weeks 0, 2 and 4). |
|
| Proportion of patients with at least one MS relapse during the study period. |
| week 24 |
| Total number of MS relapse at 24 weeks. | week 24 |
| Time to first MS relapse during the study period. | week 24 |
| Changes from baseline in the disability progression by Expanded Disability Status Scale (EDSS) at week 24. | week 24 |
| Changes from baseline in the disability progression by Multiple Sclerosis Functional Composite (MSFC) at week 24. | week 24 |
| Changes from baseline in the number of CUA lesion at week 24. | week 24 |
| Proportion of patients free from CUA lesion, gadolinium-enhancing lesions on T1 MRI and new or enlarged lesions on T2-MRI thought the 24 weeks of study. | week 24 |
| Changes from baseline in the number of Gd-enhancing T1 lesions by scan (mean number of the sum at week 12, 18 and 24) and at week 24. | week 24 |
| Changes from baseline in number of new or enlarging T2 lesions by scan (mean number of the sum at week 12, 18 and 24) and at week 24. | week 24 |
| Changes from baseline in brain global, white and gray matter volume and cervical cord volume on MRI at 24 weeks. | week 24 |
| Changes from baseline in the number of cortical lesions on MRI at 24 weeks. | week 24 |
| Changes from baseline in MR measurements of diffuse damage of brain tissue by MTR at 24 weeks | week 24 |
| Changes from baseline in MR measurements of relaxation times of T1 and T2 by MTR at 24 weeks. | week 24 |
| Changes in DTI measures as mean diffusivity (MD), fractional anisotropy (FA), radial diffusivity (Dr) and axial diffusivity (Da) at 24 weeks. | week 24 |
| Changes from baseline in cytokine production (including IFNgamma, IL-17, IL-4 and IL-10) in response to specific peptide stimulation in peripheral blood mononuclear cells (PBMCs) culture supernatants at 12 and 24 weeks. | week 24 |
| Changes from baseline in T cell proliferation to immunogenic peptides at 12 and 24 weeks. | week 24 |
| Changes from baseline in immune cell subsets in PBMCs including PBMC subtypes, T lymphocytes subpopulations and Treg subsets, CD4 and CD8 GM-CSF 'encephalitogenic' T cells and T cell subtypes by activation memory phenotype at 12 and 24 weeks. | week 24 |
| L'Hospitalet de Llobregat |
| Barcelona |
| Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de Sant Pau | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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