Hematopoietic Stem Cell Transplant in Devic's Disease

Conditions

• Devic's Disease

Eligibility Criteria

Sex

ALL

Age

16 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Hematopoietic Stem Cell Transplantation — PROCEDURE
  Infusion of participant's own stem cells
• Cyclophosphamide — DRUG
  A medication used as chemotherapy and to suppress the immune system
• G-CSF — DRUG
  A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
• rATG — DRUG
  A rabbit polyclonal antibody to lymphocytes
• Mesna — DRUG
  A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
• Rituximab — DRUG
  Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer
• Methylprednisolone — DRUG
  A corticosteroid medication used to suppress the immune system and decrease inflammation

Study Details

This study is designed to examine whether treating Devic's disease patients with high dose cyclophosphamide together with rabbit antithymocyte globulin (rATG)/rituximab (drugs which reduce the function of the immune system), followed by return of previously collected patient's stem cells will result in improvement in Devic's disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in patient's immune system, which may be causing his/her disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack patient's body. The purpose of study is to examine the safety and efficacy of this treatment. The drugs used in this study treatment are drugs for commonly used for immune suppression.

Key Dates

Start date

Oct 10, 2009

Status verified

Nov 2019

Primary completion

Nov 30, 2018

Completion

Nov 30, 2018

Study Design

Enrollment

13 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Hematopoietic Stem Cell Transplantation
  Hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide, G-CSF, Mesna, rATG, rituximab, and methylprednisolone.

Primary Outcome Measure

Survival [ Time Frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant ]

Locations (1)

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