Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Monon
Establish Tolerance in Multiple Sclerosis With Peptide-coupled, Peripheral Blood Mononuclear Cells - A MRI-controlled, Single Center, Phase I Trial in Relapsing-remitting MS Patients
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- ETIMS
Results by group
Number of Adverse Events
3 months after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| ETIMS Dose Escalation | 14 Number of AE | 9 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| ETIMS 1x10^3 | 1 | 1 (100.0%) | |
| ETIMS 1x10^5 | 1 | 0 (0.0%) | |
| ETIMS 1x10^7 | 1 | 0 (0.0%) | |
| ETIMS 1x10^8 | 1 | 0 (0.0%) | |
| ETIMS 5x10^8 | 1 | 0 (0.0%) | |
| ETIMS 1x10^9 | 2 | 0 (0.0%) | |
| ETIMS 2.5x10^9 | 1 | 0 (0.0%) | |
| ETIMS 3x10^9 | 1 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
12 months
SafetyNumber of Adverse Events
3 months after treatment
Safety
Who could take part
Relapsing and progressive · 18 to 55 · EDSS 1 to 5.5
Show the full criteria
Inclusion criteria
1. Between the ages of 18 and 55 years. 2. Patients with relapsing-remitting (Phase I/II) or secondary progressive MS (Phase I) according to published criteria 3. EDSS score between 1 and 5.5. 4. Patients are off-treatment for standard therapies (interferon-beta, glatiramer acetate, natalizumab, mitoxantrone) 5. Patients are able to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care. 6. Disease duration ≤ 5 years (Only Phase II)
Exclusion criteria
1. Diagnosis of secondary-progressive (Phase II) or primary-progressive MS, as defined by published diagnostic criteria. 2. Abnormal screening/baseline blood tests exceeding any of the limits defined 3. Pregnant or breast-feeding female. 4. History or signs of immunodeficiency. 5. Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease. 6. Splenectomy 7. History of HIV or positive HIV antibody testing 8. Serology indicating active Hepatitis B or C infection. 9. Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Open-label, single center, phase I clinical trial to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS patients.
Papers
Loading reviews and guidelines…
History
Started
Feb 2010
Main results due
Oct 2012
Finished
Oct 2012
Results posted
Apr 2015