Objective of the study
The aim of this study is to investigate the safety and tolerability of TOL001 in patients with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS). Who can participate in the study? Patients suffering from relapsing remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) are eligible to participate in the study if:
Study outline: Baseline: 8 weeks Treatment day: Single infusion with 24 hours observation at the Clinical Trial Center. Safety assessments: 2 weeks, 6 weeks, 3 months 6 months Trial registration: closed Contact and further Information can be found here in German. Team members: A. Lutterotti, R. Martin, M. Sospedra, H. Hayward-Könnecke, M. Foege, T. Ludersdorfer, T. Müller, M. Hohmann, C. Selles Moreno, M.-J. Docampo |
Establish Tolerance In MS With Peptide-Coupled, Red Blood Cells - Phase Ib Trial In Multiple Sclerosis Patients - ETIMSred
TOL001 is an experimental therapy that is being investigated by the University Hospital Zurich for the treatment of MS. This research study is being conducted at the Neurology Clinic of the University Hospital Zurich and is supported by the Wyss Translational Center Zurich. TOL001 is a cell-based therapy that includes the patient`s own (autologous) red blood cells, which are chemically coupled with seven peptides from three different myelin proteins. TOL001 is given intravenously. In this phase Ib clinical trial we will assess the safety and tolerability of a single injection of TOL001. The aim of the therapy is to stop the patient`s immune response against those peptides that are coupled on the surface of the red blood cells, i.e. to induce antigen-specific immune tolerance. The seven peptides were selected because they had previously been identified as targets of the immune response in MS patients. According to preclinical studies in animal models, peptide-coupled cells are able to induce specific immune tolerance and thereby prevent or reduce inflammatory disease activity in the brain and spinal cord. In the study, we will assess the patient`s immune response against the specific peptides and follow the effect of the treatment in the laboratory with immunologic analyses of the blood and cerebrospinal fluid. This study will be conducted in accordance with Swiss law and the current version of the Declaration of Helsinki and ICH-GCP Guideline. The study has been approved by the responsible Cantonal Ethics Committee and Swissmedic. 
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Treatment of Clinically Isolated Syndrome and Relapsing Remitting Multiple Sclerosis with RNS60 Administered Intravenously - Nano Cl iV
RNS60 is an experimental, non-approved drug that is being investigated at the University Hospital Zurich and supported by Revalesio Corporation, Tacoma, USAfor the treatment of relapsing-remitting MS (RRMS). This research study is being conducted at the Neurology Clinic of the University Hospital Zurich and the Department of Neurology of the Medical University Innsbruck. RNS60 is a novel drug, namely a sodium chloride (saline) solution, which contains oxygen in very small bubbles (nanobubbles). RNS60 does not contain a chemical substance (API). RNS60 is generated by electrokinetic processing from normal, isotonic saline (0.9% USP sodium chloride) in the presence of USP medical grade oxygen generating charge-stabilized nanostructures. According to preclinical studies in cell cultures and animal models, the drug could have a beneficial effect on inflammation in MS and potentially on disease-related changes in the nervous system as well. In the studies conducted so far, no serious side effects were observed after the administration of RNS60. In a previous safety study (Phase I) in some of the voluntary study participants, mild headache or muscle pain potentially related to RNS60, have been observed. Saline solution in RNS60 is a physiological solution, which comprises the same salt concentration as it is normally found in blood, nonetheless, this does not exclude the possibility of side effects during the study. This study is conducted in accordance with Swiss law and the current version of the Declaration of Helsinki and ICH-GCP Guideline. The study has been approved by the responsible Cantonal Ethics Committee and Swissmedic. Trial registration: closed Contact and further Information can be found here in German. Registration of the study: EudraCT 2014-000221-20 SNCTP 000000722 Team members: A. Lutterotti, R. Martin, M. Foege, C. Blumer, W. Faigle |
Structure of a nanobubble
Objective of the study
The aim of this study is to investigate the safety and efficacy of RNS60 in patients with clinically isolated syndrome (CIS) and relapsing-remitting multiple sclerosis (RRMS) and to answer the following question: Can RNS60 stabilize or improve disease activity measured on brain MRI of RRMS? Who can participate in the study? Patients suffering from clinically isolated syndrome (CIS) or early relapsing remitting multiple sclerosis (RRMS) are eligible to participate in the study if:
Dosing RNS60 will be administered intravenously. Study outline: Study Duration 40 weeks: Baseline: 8 weeks with three monthly visits Treatment phase 1: weekly infusion for 16 weeks Treatment phase 2: bi-weekly infusion for 8 weeks Treatment phase 3: four-weekly infusion for 8 weeks |
Objective of the study
The aim of this study is to investigate the safety and efficacy of OFE in patients with acute optic neuritis in the context of a clinically isolated syndrome (CIS) and relapsing-remitting multiple sclerosis (RRMS) and to answer the following questions:
Who can participate in the study? Patients suffering from clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) are eligible to participate in the study if:
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Investigator-Initiated Phase IIb Study with Hydroxytyrosol-Containing Olive Fruit Extract as a Neuroprotective Approach in Acute Optic Neuritis - OFEON trial Hydroxytyrosol (HYT) is one of the most potent, naturally occurring anti-oxidants. HYT is found at higher concentrations in olive fruit and leaves. Is properties include oral availability and immediate, active transport into the brain and spinal cord with excellent tolerability and safety in previous clinical studies. Hyt is also produced as an intermediate product in the mammalian dopamine pathway in the brain. Olive fruit extracts (OFE) or olive leaf extracts contain various amounts of HYT and other natural phenols (e.g. oleuropein). In the OFEON trial a well characterized OFE with a standardized and high content of HYT (25%) will be used. HYT is supposed to protect nerve and glial cells in the brain and spinal cord mainly via its anti-oxidant effects, but could additionally act through induction of protective genes or the chelation of metals such as iron. Its efficacy as a neuroprotective agent has been demonstrated in different cell cultures and several experimental autoimmune encephalomyelitis (EAE) models (i.e animal model of MS) and animal models of prion-induced neurodegeneration. Study outline: Treatment phase: 6 months Safety assessments: 4 weeks, 12 weeks, 6 months Dosing All patients in this trial will be offered corticosteroids (5 days 1 g/d i.v. methylprednisolone) as standard of care treatment in optic neuritis. In addition patients will receive OFE capsules (three times daily 100 mg) or placebo until end of the trial period (6 months) Trial registration: pending/ in preparation Contact and further Information can be found here in German. Team members A. Lutterotti, R. Martin, H. Hayward-Könnecke |
Experimental Research Therapies - core team
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