Status:
UNKNOWN
Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Lead Sponsor:
Organ Transplant Institute, China
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Manifestations of systemic lupus eryhematosus(SLE) may in most patients be ameliorated with medications t...
Detailed Description
Mesenchymal stem cells (MSC), or marrow stromal cells, are multipotential cells that reside within the bone marrow and can be induced to differentiate into various components of the marrow microenviro...
Eligibility Criteria
Inclusion
- Ages 18 to 50 years old.
- Meet at least 4 of 11 American College of Rheumatology (ACR) Classification criteria for SLE.
- Able to give informed consent.
- For treatment -refractory lupus nephritis, participants must fail pulse cyclophosphamide, a renal biopsy must be obtained and document either class III or IV glomerulonephritis.
Exclusion
- Pregnant women.
- Previous history of malignancy
- Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
- Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
- Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
- Transaminases greater than 2 times normal unless due to active lupus.
- Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00659217
Start Date
May 1 2008
End Date
May 1 2010
Last Update
April 16 2008
Active Locations (1)
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1
Fuzhou General Hospital
Fuzhou, Fujian, China, 350025