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

Lupus Nephritis Clinical Trial

— hUC-MSC-SLE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01539902
• Other study ID #: CT 11-03
• Status: Recruiting
• Phase: Phase 2
• First received: February 22, 2012
• Last updated: March 5, 2012
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2012
• Source: CytoMed & Beike
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Biological:
• Human Umbilical Cord derived MSCs
Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion

Drug:
• Cyclophosphamide
Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis

Locations

Country	Name	City	State
China	Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China	Kunming	Yunan

Sponsors (1)

Lead Sponsor	Collaborator
CytoMed & Beike

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes