Cardiac Safe Transplants for Systemic Sclerosis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT03593902
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

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
  • Fludarabine — DRUG
    A chemotherapy medication commonly used in the treatment of leukemia and lymphoma
  • 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 systemic sclerosis (scleroderma) patients with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy that is less toxic to your heart.

Key Dates

Start date
May 17, 2018
Status verified
Jun 2020
Primary completion
Oct 3, 2019
Completion
Oct 9, 2019

Study Design

Enrollment
9 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, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.

Primary Outcome Measure

Change in Skin Score by mRSS [ Time Frame: Pre Treatment and Post Treatment ]

Locations (2)

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

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

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