Status:
TERMINATED
Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism
Lead Sponsor:
Northwestern University
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Peripheral blood stem cell mobilization (PBSC) PBSC will be mobilized with G-CSF (dose may be adjusted down to 5-10 ug/kg/day by PI for toxicity, e.g. flu-like symptoms) with stem cell collection beg...
Eligibility Criteria
Inclusion
- Participant Inclusion Criteria:
- Age \> 18 and \< 60 years at time of pre-transplant evaluation.
- An established clinical diagnosis of rheumatoid arthritis by American College of Rheumatology criteria.
- Patients must have failed an autologous hematopoietic transplant or have failed to respond to either methotrexate or leflunomide in combination with a TNF inhibitor. Failure is defined as an inability to tolerate treatment with at least 6 swollen joints and 20 involved joints or inability to answer at least 70% of HAQ questions with "no difficulty" despite 2 or more months of treatment.
- Ability to give informed consent.
- Patient must have a HLA matched sibling donor at the A, B, C, and DR loci to proceed or HLA matched cord blood donor.
- If donor is HLA matched cord blood, cord blood stem cells will be obtained from the NMDP (1-800-548-1375) and one or two units of HLA matched cord blood will be infused on day zero.
- Participant Exclusion Criteria
- History of coronary artery disease, or documented congestive heart failure.
- HIV positive.
- Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemoradiotherapy.
- Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis.
- Positive pregnancy test, inability or unwillingness to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
- Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
- FEV1/FVC \< 70% of predicted, DLCO \< 40% of predicted.
- Resting LVEF \< 45 %.
- Bilirubin \> 2.0 mg/dl (unless due to Gilberts), transferase (AST) \> 2.5 x upper limit of normal.
- Serum creatinine \> 2.0 mg/dl.
- Donor Exclusion Criteria
- Age \< 18 years.
- Positive for HIV-1, HIV-2, HTLV-I, HTLV-II.
- Active hepatitis B or C.
- History of a malignancy except for a localized cancer such as skin cancer that is deemed cured.
- History of myocardial infarction or congestive heart failure.
- Inability to give informed consent.
- Current pregnancy.
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00282412
Start Date
September 1 2002
End Date
June 1 2016
Last Update
July 30 2018
Active Locations (1)
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1
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611