Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells (ETIMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01414634
First received: August 8, 2011
Last updated: April 8, 2015
Last verified: April 2015
Results First Received: January 24, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Sclerosis, Relapsing-Remitting
Intervention: Biological: ETIMS

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ETIMS 1x10^3 ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
ETIMS 1x10^5 ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
ETIMS 1x10^7 ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
ETIMS 1x10^8 ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
ETIMS 5x10^8 ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
ETIMS 1x10^9 ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
ETIMS 2.5x10^9 ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
ETIMS 3x10^9 ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion

Participant Flow:   Overall Study
    ETIMS 1x10^3     ETIMS 1x10^5     ETIMS 1x10^7     ETIMS 1x10^8     ETIMS 5x10^8     ETIMS 1x10^9     ETIMS 2.5x10^9     ETIMS 3x10^9  
STARTED     1     1     1     1     1     2     1     1  
COMPLETED     1     1     1     1     1     2     1     1  
NOT COMPLETED     0     0     0     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ETIMS Dose Escalation ETIMS: injection of peptide-coupled PBMC by i.v. infusion

Baseline Measures
    ETIMS Dose Escalation  
Number of Participants  
[units: participants]
  9  
Age  
[units: years]
Median (Full Range)
  42  
  (27 to 49)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     0  
Gender  
[units: participants]
 
Female     8  
Male     1  
Region of Enrollment  
[units: participants]
 
Germany     9  



  Outcome Measures

1.  Primary:   Number of Adverse Events   [ Time Frame: 3 months after treatment ]

2.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Roland Martin
Organization: Neuroimmunology and MS Research, Department of Neurology, University Hospital Zürich, 8091 Zürich, Switzerland
phone: 044 255 11 25
e-mail: roland.martin@usz.ch


Publications of Results:

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01414634     History of Changes
Other Study ID Numbers: inims-oo1
Study First Received: August 8, 2011
Results First Received: January 24, 2014
Last Updated: April 8, 2015
Health Authority: Germany: Paul-Ehrlich-Institut
Germany: Federal Institute for Drugs and Medical Devices