Worms for Immune Regulation of Multiple Sclerosis (WIRMS)

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple sclerosis, Hookworm larvae, Necator americanus, Treg cells Read More

Inclusion Criteria:

• Relapsing remitting MS (RRMS) (McDonald criteria) and secondary MS with super imposing relapse on condition that they fulfil the next conditions, MRI scan consistent with MS by Barkhof or Fazekas criteria
• Patients with at least 1 relapse in the last 12 months or 2 in the last 24 months;
• Patients with Expanded disability status scale (EDSS) score in the range of 0 to 5.5 at the screening and week 0 visit
• Patients of both genders, age >18 years and < 65 years
• Women of child bearing potential, (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study.
• Be able and willing to comply with study visits and procedures per protocol.
• Understand and sign consent form at the screening

Exclusion Criteria:

No populations at risk of severe illness or death will be included in this study

• Life expectancy < 6 months.
• Patient is < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.
• Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
• Patients with severe and/or uncontrolled medical condition.
• Pregnancy, lactation or intention to become pregnant during the course of the study (please also see above under inclusion criterion 5)
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Anaemia (Hb <10 g/dL for females, <11 g/dL for males)
• Prior or present evidence of parasitic infection; prior treatment with anti-helminthic drugs in the last 6 years.
• Patient with serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol
• History of poor compliance or history of drug/alcohol abuse, or excessive alcohol consumption that would interfere with the ability to comply with the study protocol,
• Severe asthma, allergy, other autoimmune disease or any condition that the physician judges could be detrimental to subjects participating in this study; including deviations deemed clinically important from normal clinical laboratory

Previous treatment

• Treatment with interferon or glatiramer acetate within 8 weeks prior to baseline or immunosuppressive drugs within 12 weeks prior to baseline
• Treatment with bone marrow transplantation, total lymphoid irradiation, monoclonal antibodies (other than natalizumab, umbilical cord stem cells, AIMSPRO at any time prior to baseline
• Treatment with corticosteroids or ACTH within 4 weeks prior to baseline
• Treatment with any investigational agent within 12 weeks prior to baseline