Assessing safety and feasibility of cell therapy for early multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and feasibility of using autologous Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTL) in patients experiencing their first clinical episode suggestive of multiple sclerosis (MS). The study focuses on patients aged 18 to 45 who have a clinically isolated syndrome and meet specific MRI and cerebrospinal fluid criteria. By infusing these specially targeted immune cells, the trial aims to understand their potential role in managing MS, which is thought to be linked to EBV infection. The approach seeks to address the altered immune response observed in MS patients and explore a novel cellular therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18\<Age≤45 years
* Patients with :

  * A clinically isolated syndrome (first acute or sub acute neurological event consistent with demyelination \[i.e. optic neuritis, spinal cord syndrome, brainstem/ cerebellar syndrome\])
  * And a MRI scan showing dissemination of MRI lesions in space based on 2017 McDonald criteria At least 1 lesion detected in 2 or more following locations (sites) periventricular, cortical or juxtacortical, infratentorial, spinal cord
  * With a possible dissemination in time based on the revised McDonald cirteria and evicenced on simultaneous detection of one Gadolinium (Gd) enhancing and non-Gd enhancing lesions
  * Or demonstration of CSF-specific oligoclonal bands (OCBs)
* EDSS Score \<3
* Patients covered by health care insurance (social security)
* Written informed consent obtained.
* Onset of symptoms occurring within 60 days of inclusion
* Patients with HIV, HTLV, Hepatitis B, C Syphilis testing negative within 30 days
* Positive EBV serology
* White blood cell count (Leukocytes) \> 750/mm3
* Negative pregnancy test

Exclusion Criteria:

* Patients with clinically definite multiple sclerosis
* Patients known to have HIV, HTLV Hepatitis A, B, C or Syphilis infections or patient with active uncontrolled systemic bacterial, viral, parasitic or fungal infections.
* Patients with white blood cell count (Leukocytes) \< 750/mm3
* Pregnant or breast feeding women
* Patient with childbearing potentiel refusing efficient contraceptive method
* Patients wishing to be pregnant during the course of the study
* Patients under legal guardianship
* Concomitant participation of any other trial
* Patients with mental or psychiatry condition unable to understand the trial
* Patients with any medically unstable condition or any health conditions that may impact the safety of the patient as determined by the investigator or patient with any stable condition treated with immunotherapy
* Patients with a history of cancer within 5 years or progressive cancer except for basal or cell skin lesions surgically excised and cured, in situ cervical cancer
* Patients unable to comply with protocol.
* Contraindication for MRI or/and any known history of hypersensitivity to contrast medium
* Patients currently treated with immunosuppressive drugs including oral or systemic corticosteroids

Where it's running

• University Hospital
  Nantes, France Recruiting

Study contacts

• Study coordinator: David LAPLAUD, Doctor
• Email: david.laplaud@univ-nantes.fr
• Phone: + 33 (0)2 40 16 52 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.