Autologous Transplant To End NMO Spectrum Disorder

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT03829566
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

  • Devic's Disease
  • NMO Spectrum Disorder
  • Neuromyelitis Optica

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer
  • Cyclophosphamide — DRUG
    A medication used as chemotherapy and to suppress the immune system
  • Mesna — DRUG
    A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
  • rATG — DRUG
    A rabbit polyclonal antibody to lymphocytes
  • Methylprednisolone — DRUG
    A corticosteroid medication used to suppress the immune system and decrease inflammation
  • G-CSF — DRUG
    A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
  • IVIg — BIOLOGICAL
    Pooled immunoglobulin (IgG) from thousands of plasma donors that has immunomodulatory and anti-inflammatory effects
  • Autologous Stem Cells — BIOLOGICAL
    Infusion of patient's own stem cells

Study Details

This study is designed to treat your disease with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy to reset your immune system and to determine if your disease will go into long-term remission.

Key Dates

Start date
Nov 30, 2019
Status verified
Nov 2019
Primary completion
Jan 31, 2025
Completion
Nov 28, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hematopoietic Stem Cell Transplantation
    Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
Northwestern University, Feinberg School of MedicineChicagoIllinois60611-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILNorthwestern University, Feinberg School of Medicine· Chicago, IL

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