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

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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
Sponsor:
Information provided by (Responsible Party):
CytoMed & Beike

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Biological: Human Umbilical Cord derived MSCs Drug: Cyclophosphamide Phase 2

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by CytoMed & Beike:
MSC for the treatment of Lupus Nephritis
Additional relevant MeSH terms:
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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