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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Biological: Human Umbilical Cord derived MSCs
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Patients with any of the following are not eligible for enrollment into the study: Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test. Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study. Those persons directly involved in the conduct of the study. Serum creatinine more than 250 µmol/L. White blood cell (WBC) count of less than 3.5 X 109/L. Active peptic ulcer disease. Active systemic infection. History of alcohol or substance abuse. History of malignancy within previous 5 years. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Umbilical Cord derived MSCs<br> | Biological: Human Umbilical Cord derived MSCs<br>* Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion<br>* Other names: Allogeneic stem cells derived from umbilical cord;|
| Placebo Comparator: Cyclophosphamide<br> | Drug: Cyclophosphamide<br>* Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis<br>* Other names: Immunosupressive agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and Safety | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSC for the treatment of Lupus Nephritis