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Clinical Trial Summary

One of the possible options for the treatment of MS at present is a high-dose immunosuppressive therapy followed by autologous hematopoietic stem cell transplantation (HIST-AHSCT), which is a highly effective treatment for patients with relapsing-remitting MS. This method of MS treatment was introduced in 1997. Significant complications and mortality associated with HIST-ATHSC is an obstacle to broad use of this method. The risk is even greater in patients with advanced disease, long duration of previous treatment and aggressive forms of MS. Despite toxicity certain progressive cases of MS are still an indication for HIST-autoHSCT. Most commonly used conditioning regimens for multiple sclerosis include high-dose cyclophosphamide. One of the options to reduce cyclophosphamide-related toxicity and dose is addition of fludarabine. Fludarabine is a cytostatic drug, an antimetabolite from the group of purine antagonists. It has a pronounced immunosuppressive activity and no overlapping toxicity with cyclophosphamide. The study will evaluate the safety and efficacy of this combination.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05832515
Study type Interventional
Source St. Petersburg State Pavlov Medical University
Contact Alexey Yu Polushin
Phone +79118167559
Email alexpolushin@yandex.ru
Status Recruiting
Phase Phase 1
Start date October 1, 2020
Completion date December 1, 2026

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