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

Phase 1/2 Completed 9 enrolled University Medical Center Hamburg-Eppendorf

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2010-02
Primary completion: 2012-10
Completion: 2012-10

Publications

Results Lutterotti A, Yousef S, Sputtek A, Sturner KH, Stellmann JP, Breiden P, Reinhardt S, Schulze C, Bester M, Heesen C, Schippling S, Miller SD, Sospedra M, Martin R. Antigen-specific tolerance by autologous myelin peptide-coupled cells: a phase 1 trial in multiple sclerosis. Sci Transl Med. 2013 Jun 5;5(188):188ra75. doi: 10.1126/scitranslmed.3006168.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ETIMS	Cell therapy	1000 cells	Intravenous
Subject	ETIMS	Cell therapy	100000 cells	Intravenous
Subject	ETIMS	Cell therapy	1e+07 cells	Intravenous
Subject	ETIMS	Cell therapy	1e+08 cells	Intravenous
Subject	ETIMS	Cell therapy	5e+08 cells	Intravenous
Subject	ETIMS	Cell therapy	1e+09 cells	Intravenous
Subject	ETIMS	Cell therapy	2.5e+09 cells	Intravenous
Subject	ETIMS	Cell therapy	3e+09 cells	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications