Status:
UNKNOWN
Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Nanjing Medical University
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Refractory Systemic Lupus Erythematosus
Eligibility:
All Genders
15-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will explore a new approach to treat patients with a medical condition known as systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new population of c...
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell (AlloMSC) transplantation in patients with refractory SLE. Patients with Lupus ...
Eligibility Criteria
Inclusion
- All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8;
- Lupus nephritis with 24h urine protein≥1g;
- Refractory disease as determined by failure of the following regimens:
- Trial of corticosteroids (oral prednisone more than 20 mg/day);
- Trial of cyclophosphamide 0.4 \~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as MMF 2 g / day, for three months;
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
- Willing to use contraception throughout the study and for 12 mos following treatment.
Exclusion
- Abnormal liver function (ALT higher than 3 times the normal value);
- End-stage renal failure;
- Severe heart and pulmonary failure, or other important organs damage;
- Undercontrolled infections
- Pregnant or breast feeding women, male or female who intended to recent pregnancy.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00698191
Start Date
March 1 2007
End Date
December 1 2012
Last Update
June 17 2008
Active Locations (1)
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1
Department of Rheumatology and Immunology, Nanjing University Medical College Affiliated Drum Tower Hospital
Nanjing, Jiangsu, China, 210008