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

Phase 2

• Conditions: Lupus Nephritis
• Interventions: Biological: Human Umbilical Cord derived MSCs; Drug: Cyclophosphamide

• Registration Number: NCT01539902
• Lead Sponsor: CytoMed & Beike

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 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-28
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-05
• Last Update Posted: 2012-03-06
• Primary Completion: 2013-03
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Exclusion Criteria

Patients with any of the following are not eligible for enrollment into the study:

1. 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.
2. Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
3. Those persons directly involved in the conduct of the study.
4. Serum creatinine more than 250 µmol/L.
5. White blood cell (WBC) count of less than 3.5 X 109/L.
6. Active peptic ulcer disease.
7. Active systemic infection.
8. History of alcohol or substance abuse.
9. History of malignancy within previous 5 years.
10. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Umbilical Cord derived MSCs	Human Umbilical Cord derived MSCs	-
Cyclophosphamide	Cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Efficacy and Safety	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.

Trial Locations

Locations (1)

Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China; 🇨🇳 Kunming, Yunan, China