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Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis — hUC-MSC-SLE  

Lupus Nephritis Clinical Trial

Official title:
A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01539902
Study type Interventional
Source CytoMed & Beike
Contact
Status Recruiting
Phase Phase 2
Start date February 2012
Completion date May 2013
View Details
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