Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis (hUC-MSC-SLE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2012 by CytoMed & Beike.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

CytoMed & Beike

ClinicalTrials.gov Identifier:

NCT01539902

First received: February 22, 2012

Last updated: March 5, 2012

Last verified: March 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Lupus Nephritis	Biological: Human Umbilical Cord derived MSCs Drug: Cyclophosphamide	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Cyclophosphamide

Genetic and Rare Diseases Information Center resources: Lupus Nephritis Glomerulonephritis

U.S. FDA Resources

Further study details as provided by CytoMed & Beike:

Primary Outcome Measures:

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.


Estimated Enrollment:	25
Study Start Date:	February 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	16 Years to 65 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539902

Locations


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

Sponsors and Collaborators

CytoMed & Beike

More Information


Responsible Party:	CytoMed & Beike
ClinicalTrials.gov Identifier:	NCT01539902 History of Changes
Other Study ID Numbers:	CT 11-03
Study First Received:	February 22, 2012
Last Updated:	March 5, 2012

Keywords provided by CytoMed & Beike:


MSC for the treatment of Lupus Nephritis

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on August 18, 2017

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