Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis (hUC-MSC-SLE)
|ClinicalTrials.gov Identifier: NCT01539902|
Recruitment Status : Unknown
Verified March 2012 by CytoMed & Beike.
Recruitment status was: Recruiting
First Posted : February 28, 2012
Last Update Posted : March 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Biological: Human Umbilical Cord derived MSCs Drug: Cyclophosphamide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||May 2013|
|Experimental: Human Umbilical Cord derived MSCs||
Biological: Human Umbilical Cord derived MSCs
Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion
Other Name: Allogeneic stem cells derived from umbilical cord
|Placebo Comparator: Cyclophosphamide||
Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
Other Name: Immunosupressive agent
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539902
|Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China||Recruiting|
|Kunming, Yunan, China, 650000|
|Contact: PeiLian Zhang, Dr firstname.lastname@example.org|
|Principal Investigator: DanQi Deng, Professor|
|Sub-Investigator: PeiLian Zhang, Dr|