High-dose immunosuppressive therapy followed by stem cell transplantation for 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 investigates the use of high-dose immunosuppressive therapy combined with autologous hematopoietic stem cell transplantation (AHSCT) in patients with multiple sclerosis (MS). The study specifically evaluates the conditioning regimen that includes fludarabine and cyclophosphamide to reduce toxicity while maintaining efficacy. Participants will be monitored for safety and effectiveness, particularly those with relapsing-remitting forms of MS who have not responded to standard treatments. The trial aims to provide insights into optimizing treatment protocols for MS patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-65;
* 1.0-6.5 points on the EDSS scale (for MS);
* Length of illness - any;
* Disease progression during the last 6 months while taking drugs of 1st and 2nd lines;
* An established and confirmed diagnosis of an autoimmune disease in the previous stages of treatment;
* Ineffectiveness, inaccessibility or intolerance of Disease-Modifying Therapies;
* Relapse after AHSCT.
* Absence of severe concomitant somatic pathology;
* Left ventricular injection fraction \> 50%;
* Karnofsky Performance Score (KPS) \> 30%;
* The ability to take oral medications;
* Life expectancy is more than 1 month;
* Signed informed consent of the patient or legal representatives.

Exclusion Criteria:

* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
* Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
* Creatinine clearance \< 60 mL/min
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky performans status \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent

Where it's running

• First Pavlov State Medical University of St. Petersburg
  Saint Petersburg, Russia Recruiting

Study contacts

• Principal investigator: Ivan S Moiseev — Pavlov First Saint Petersburg State Medical University
• Study coordinator: Alexey Yu Polushin
• Email: alexpolushin@yandex.ru
• Phone: +79118167559

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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.