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Trial record 18 of 35 for:    stem cell lupus

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

Tracking Information
First Submitted Date  ICMJE February 22, 2012
First Posted Date  ICMJE February 28, 2012
Last Update Posted Date March 6, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
Official Title  ICMJE A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • 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
  • Drug: Cyclophosphamide
    Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
    Other Name: Immunosupressive agent
Study Arms  ICMJE
  • Experimental: Human Umbilical Cord derived MSCs
    Intervention: Biological: Human Umbilical Cord derived MSCs
  • Placebo Comparator: Cyclophosphamide
    Intervention: Drug: Cyclophosphamide
Publications * Deng D, Zhang P, Guo Y, Lim TO. A randomised double-blind, placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis. Ann Rheum Dis. 2017 Aug;76(8):1436-1439. doi: 10.1136/annrheumdis-2017-211073. Epub 2017 May 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 22, 2012)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2013
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01539902
Other Study ID Numbers  ICMJE CT 11-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CytoMed & Beike
Study Sponsor  ICMJE CytoMed & Beike
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CytoMed & Beike
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP