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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— ETIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414634
• Other study ID #: inims-oo1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 8, 2011
• Last updated: April 8, 2015
• Start date: February 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Biological:
• ETIMS
injection of peptide-coupled PBMC by i.v. infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

References & Publications (1)

Lutterotti A, Yousef S, Sputtek A, Stürner 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 mu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability		12 months	Yes
Primary	Number of Adverse Events		3 months after treatment	No