Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulato
Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Tolerogenic Dendritic cells loaded with myelin peptides
What it measured
Main measures
number of patients with adverse events
after 12 weeks of follow up
Safety
Other measures (7)
Multiple Sclerosis Functional Composite scale
after 12 weeks of follow up
Multiple Sclerosis Spasticity Scale
after 12 weeks of follow up
SpasticityExpanded Disability Status Scale
after 12 weeks of follow up
Disability progressionSF36 Health Status questionnaire
after 12 weeks of follow up
Quality of life (reported by participants)EuroQol5D
after 12 weeks of follow up
Changes in immunological profile
after 12 weeks of follow up
number of disease outbreaks
after 12 weeks of follow up
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
* patients with Multiple sclerosis or neuromyelitis optica * diagnosed more than a year before inclusion * Expanded Disability Status Scale between 3.0 and 8.5 * all subtypes of multiple sclerosis or Neuromyelitis optica * Multiple Sclerosis patients who have previously been offered therapeutic alternatives available in indications and either decline or that after receiving treatment for at least 6 months have had an outbreak or an increase of at least 1 point on the Expanded Disability Status Scale (EDSS) (non-responders) or who have not tolerated treatment * Patients with Neuromyelitis optica (NMO) in stable immunomodulatory treatment in the past 6 months or without treatment because they are not candidates to receive it
Exclusion criteria
* Corticosteroid treatment in the last 30 days * Presence of an outbreak in the last month * Inability to perform brain Magnetic resonance imaging (with paramagnetic contrast) * Serious systemic diseases, including Hepatitis B virus, Hepatitis C Virus, and Human Immunodeficiency Virus. Uncontrolled hypertension, insulin-dependent diabetes mellitus, heart disease or kidney failure or severe respiratory * Personal history of cancer or family history of known hereditary cancer * patient participating in other experimental study in the last 3 months * women childbearing-aged that do not use effective contraceptive methods * pregnant or breastfeeding women
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
First in human study to assess the tolerability and safety profile of treatment with dendritic cell in patients with multiple sclerosis or neuromyelitis optica.
Papers
Results
The Biologic IRL201805 Alters Immune Tolerance Leading to Prolonged Pharmacodynamics and Efficacy in Rheumatoid Arthritis Patients.Int J Mol Sci · 2024
Results
Immune tolerance in multiple sclerosis and neuromyelitis optica with peptide-loaded tolerogenic dendritic cells in a phase 1b trial.Proc Natl Acad Sci U S A · 2019
Loading reviews and guidelines…
Related trials
- A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory
Phase 1 · Not yet recruiting
Still running
- A Study of C-CAR168 in the Treatment of Central Nervous System Autoimm
Phase 1 · Not yet recruiting
Still running
- Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimm
Phase 1 · Withdrawn
Stopped
- Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases
Early phase 1 · Not yet recruiting
Still running
- A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory
Phase 1 · Recruiting
Still running
- Neurofilament Light Chain ,Chitinase-3 Like-1 Proteins and Plasmacytoi
Status unknown
No results found
History
Started
Sept 2015
Main results due
Jul 2019
Finished
Jul 2019