Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis (hUC-MSC-SLE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lupus Nephritis | Biological: Human Umbilical Cord derived MSCs Drug: Cyclophosphamide | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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 |
Drug: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
China, Yunan | |
Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China | Recruiting |
Kunming, Yunan, China, 650000 | |
Contact: PeiLian Zhang, Dr mzczpl1968@163.com | |
Principal Investigator: DanQi Deng, Professor | |
Sub-Investigator: PeiLian Zhang, Dr |
Responsible Party: | CytoMed & Beike |
ClinicalTrials.gov Identifier: | NCT01539902 |
Other Study ID Numbers: |
CT 11-03 |
First Posted: | February 28, 2012 Key Record Dates |
Last Update Posted: | March 6, 2012 |
Last Verified: | March 2012 |
MSC for the treatment of Lupus Nephritis |
Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Cyclophosphamide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |