Clinical Trial: Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
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 Summary:
Inclusion criteria:
- Male or non-pregnant females age 16 to 65 years inclusive.
- Written informed consent obtained from patient or parents/guardian.
- Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
- Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.
Sponsor: CytoMed & Beike
Current Primary Outcome: Efficacy and Safety [ Time Frame: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: CytoMed & Beike
Dates:
Date Received: February 22, 2012
Date Started: February 2012
Date Completion: May 2013
Last Updated: March 5, 2012
Last Verified: March 2012
