Fecal Microbiota Transplantation After Autologous HSCT in Patients With Multiple Sclerosis

NCT04203017 | Terminated Phase 1

• 1 other identifier: ms/fmt
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• To evaluate effectiveness of autoHSCT in combination with FMT in patients with refractory multiple sclerosis

  Multiple sclerosis progression free survival

  365 days

Secondary Outcomes (7)

• To evaluate overall survival after autoHSCT in combination with FMT in patients with refractory multiple sclerosis

  365 days

• To evaluate adverse effects after FMT in immunocompromised patients

  365 days

• Quality of life status 1

  365 days

• Quality of life status 2

  365 days

• Evaluation of Immune system reconstitution after autoHSCT 1

  365 days

Study Arms (1)

AutoHSCT + FMT

EXPERIMENTAL

AutoHSCT with reduced intensity condition regimen (RIC). FMT starting D+60 up to D+120 via po capsules: 30 capsules with fecal transplant divided in two consecutive days (more accurate capsules amount is according to patients body weight)

Biological: allogeneic fecal microbiota

Interventions

allogeneic fecal microbiota BIOLOGICAL

All patients receive autoHSCT with RIC (Cyclophosphamide, Antithymocyte globulin, Rituximab). After immune system reconstitution (approximately starting D+60 up to D+120), patients will receive FMT from healthy donor via po capsules.

AutoHSCT + FMT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis: Multiple sclerosis (Relapsing-Remitting, Secondary-Progressive, Primary-Progressive)
• AutoHSCT
• Signed informed consent
• No second tumors
• No severe concurrent illness
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

Pavlov First Saint-Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Boris Afanasyev, Professor

  Pavlov First Saint Petersburg State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for research, Raisa Gorbacheva Memorial Research Institute for Pediatric Oncology, Hematology and Transplantation

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: December 18, 2019
• Study Start: June 1, 2019
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

RU (1)