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Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism

NCT00282412 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-07-30

Study results available
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Summary

Rheumatoid arthritis disease is believed to be due to immune cells, cells that normally protect the body and are now causing damage to the body. Risk of death is highest in people with twenty or more joints actively involved with disease, positive rheumatoid factor, an elevated sedimentation rate (laboratory measures of active inflammation), and patients with limitation of daily activities (trouble doing simple things like opening a carton of milk). In these high risk patients, life is significantly shortened. Death is usually from heart disease, kidney failure, neck dislocation, broken hip bones, or blood clots to the lung. In this study we use moderate dose chemotherapy (cyclophosphamide and fludarabine) and CAMPATH-1H (a protein that kills the immune cells that are thought to be causing the disease), followed by infusion of blood stem cells that have been collected from the patient's brother or sister (allogeneic stem cell transplant). The purpose of the moderate dose chemotherapy and CAMPATH-1H is to destroy the cells in the immune system and to allow the cells from the patient's brother or sister to grow. The purpose of the stem cell infusion is to restore blood cell production, which will be severely impaired by the moderate dose chemotherapy and CAMPATH-1H, and to produce a normal immune system that will no longer attack the body.

Conditions

Interventions

BIOLOGICAL

Hematopoietic Stem Cell Transplantation

Allogeneic Hematopoietic Stem Cell Transplantation

DRUG

Fludarabine

inhibits DNA synthesis or repair

DRUG

Cyclophosphamide

Causes prevention of cell division by forming adducts with DNA

DRUG

Campath 1H

humanized monoclonal antibody against CD52 antigen

DRUG

GCSF

Hematopoietic growth factor

DRUG

Cyclosporins

immune suppressive drug

DRUG

Mycophenolate Mofetil

immune suppressive drug

Sponsors & Collaborators

Principal Investigators

  • Richard Burt, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00282412 on ClinicalTrials.gov