NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: St. Petersburg State Pavlov Medical University
Conditions: Multiple Sclerosis
Interventions: allogeneic fecal microbiota
Countries: Russia
The hypothesis of the study is that according to modern data, the pathogenesis of multiple sclerosis is inextricably linked to the patient's microbiota. Therefore, transplantation of a normal fecal microbiota (FMT) can improve the outcome of autologous hematopoietic stem cell transplantation (autoHSCT) by increasing the disease-free period and disease progression suspension for at least 5 years after transplantation, which meets the NEDA (No Evidence of Disease Activity) criteria, satisfying the current trends of clinical neurology.
Sex: ALL
Age: 18 Years to 55 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Diagnosis: Multiple sclerosis (Relapsing-Remitting, Secondary-Progressive, Primary-Progressive) * AutoHSCT * Signed informed consent * No second tumors * No severe concurrent illness * 1.0-6.5 points by EDSS * Disease duration less than 20 years * Disease progression on 1 and/or 2 line therapy (1 point EDSS 1.0-6.0 and 0,5 point EDSS 6.0-6.5) 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 index \<30% * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign informed consent
- Saint Petersburg, Russia