Phase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus Erythematosus
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- British Isles Lupus Assessment Group score (BILAG)
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments. The underlying hypothesis is that the active SLE condition is caused by an abnormal immune homeostasis that can be restored by MSCT.
Detailed Description
Inclusion Criteria: 1. All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8; 2. Lupus nephritis with 24h urine protein≥1g; 3. 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 mycophenolate mofetil 2 g / day, for three months; 4. 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; 5. Willing to use contraception throughout the study and for 12 months following treatment
Investigators
Lingyun Sun
Department of Rheumatology and Immunology
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Eligibility Criteria
Inclusion Criteria
- •All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 60 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 mycophenolate mofetil 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 months following treatment
Exclusion Criteria
- •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;
- •Uncontrolled infections
- •Pregnant or breast feeding women, male or female who intended to recent pregnancy
Outcomes
Primary Outcomes
British Isles Lupus Assessment Group score (BILAG)
Time Frame: up to 12 months
Secondary Outcomes
- Renal function (GFR, Blood Urea Nitrogen, urinalysis)(pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation (for GFR assessed at baseline and 12 months after MSCT))
- Lupus serology (Alb, ANA, dsDNA, C3, C4)(pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation)