NCT01539902

Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: CytoMed & Beike · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	Human Umbilical Cord derived MSCs	Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion
DRUG	Cyclophosphamide	Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2012-02-28
• Last updated: 2012-03-06

Locations

1 site across 1 country: China