Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis (hUC-MSC-SLE)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 email@example.com|
|Principal Investigator: DanQi Deng, Professor|
|Sub-Investigator: PeiLian Zhang, Dr|