Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells (ETIMS)
8 april 2015 uppdaterad av: Universitätsklinikum Hamburg-Eppendorf
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
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Open-label, single center, phase I dose-escalation study to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of a single infusion of autologous peripheral blood mononuclear cells chemically coupled with seven myelin peptides (MOG1-20, MOG35-55, MBP13-32, MBP83-99, MBP111-129, MBP146-170, and PLP139-154) in Multiple Sclerosis patients who were off-treatment for standard therapies.
Neurological, magnetic resonance imaging, laboratory, and immunological examinations were performed to assess the safety, tolerability, and in vivo mechanisms of action of this regimen.
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Fas 2
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Between the ages of 18 and 55 years.
- Patients with relapsing-remitting (Phase I/II) or secondary progressive MS (Phase I) according to published criteria
- EDSS score between 1 and 5.5.
- Patients are off-treatment for standard therapies (interferon-beta, glatiramer acetate, natalizumab, mitoxantrone)
- 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.
- Disease duration ≤ 5 years (Only Phase II)
Exclusion Criteria:
- Diagnosis of secondary-progressive (Phase II) or primary-progressive MS, as defined by published diagnostic criteria.
- Abnormal screening/baseline blood tests exceeding any of the limits defined
- Pregnant or breast-feeding female.
- History or signs of immunodeficiency.
- Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.
- Splenectomy
- History of HIV or positive HIV antibody testing
- Serology indicating active Hepatitis B or C infection.
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ETIMS 1x10^3
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^3 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
Experimentell: ETIMS 1x10^5
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^5 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
Experimentell: ETIMS 1x10^7
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^7 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
Experimentell: ETIMS 1x10^8
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^8 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
Experimentell: ETIMS 5x10^8
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 5x10^8 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
Experimentell: ETIMS 1x10^9
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^9 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
Experimentell: ETIMS 2.5x10^9
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 2.5x10^9 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
Experimentell: ETIMS 3x10^9
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 3x10^9 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Tidsram: 12 months
|
12 months
|
|
Number of Adverse Events
Tidsram: 3 months after treatment
|
3 months after treatment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Christoph Heesen, MD, Department of Neurology, University Clinic Eppendorf (UKE)
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2010
Primärt slutförande (Faktisk)
1 oktober 2012
Avslutad studie (Faktisk)
1 oktober 2012
Studieregistreringsdatum
Först inskickad
8 augusti 2011
Först inskickad som uppfyllde QC-kriterierna
10 augusti 2011
Första postat (Uppskatta)
11 augusti 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 maj 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 april 2015
Senast verifierad
1 april 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- inims-oo1
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