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

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CytoMed & Beike
• Treatments: Cyclophosphamide

Criteria

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.