Föreläsningar och seminarier Pediatric Oncology seminar - Olle Ringdén, Behnam Sadeghi and Britt Gustafsson

Summary: The aim is to establish placenta-derived stromal cells (DSCs) as a therapy for Acute Hemorragic Cystitis (aHC) after Hematopoietic cell transplantation (HCT). HCT is an established therapy for heamtological malignancies and some benign hematological diseases. aHC is a severe complication, with an incidence of 10-70%. Symptoms of aHC goes from microscopic to macroscopic hematuria with clots and renal bladder damge, associated with high morbidity and mortality. Treatment options are symptomatic. All HCT centras in Sweden, Norway and Finland are involved in the project and will recruit the patients developing aHC.

This is a prospective double-blind multi-center randomized trial comparing DSCs versus placebo. All patients who develop grade 3-4 of aHC after HCT will be randomized to DSC or placebo. Primary endpoint is the mean time to cease macroscopic hematuria (MTCH). In our pilot study MTCH was 3 days. From historical report the MTCH was of 23 days. Considering the differences in MTCH between the groups, by the power of 90% and alpha error of 5% we need 19 patients in each group. To exclude the effects of confounding variables we stratified study population for age and grade of HC. Therefore, we totally need 38 patients and with 10% loss we need 42 patients for the whole study. The study is approved by the ethical committée.

Moderator: Petter Svenberg