Lupus Nephritis
Conditions
Keywords
MSC for the treatment of Lupus Nephritis
Brief summary
The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.
Detailed description
Inclusion criteria: 1. Male or non-pregnant females age 16 to 65 years inclusive. 2. Written informed consent obtained from patient or parents/guardian. 3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score\>8 or BILAG score A/B. 4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.
Interventions
BIOLOGICALHuman Umbilical Cord derived MSCs
Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion
DRUGCyclophosphamide
Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
Sponsors
CytoMed & Beike
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant females age 16 to 65 years inclusive. 2. Written informed consent obtained from patient or parents/guardian. 3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score\>8 or BILAG score A/B. 4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis
Exclusion criteria
Patients with any of the following are not eligible for enrollment into the study: 1. Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test. 2. Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study. 3. Those persons directly involved in the conduct of the study. 4. Serum creatinine more than 250 µmol/L. 5. White blood cell (WBC) count of less than 3.5 X 109/L. 6. Active peptic ulcer disease. 7. Active systemic infection. 8. History of alcohol or substance abuse. 9. History of malignancy within previous 5 years. 10. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and Safety | 6 months | The efficacy measure is remission of nephritis (combined partial and complete remission) at 6 months defined as * Stabilization or improvement in renal function and * Urinary RBC of less than 10 per HPF and * Reduction of proteinuria to less than 3 g/day if baseline proteinuria was more than 3 g/day and at least a 50% reduction in proteinuria, or to less than 1 g/day if the baseline proteinuria was in the subnephrotic range. |
Countries
China
Outcome results
None listed