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Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT03458156
Recruitment Status : Unknown
Verified March 2018 by Liu Jing, The First Affiliated Hospital of Dalian Medical University.
Recruitment status was:  Active, not recruiting
First Posted : March 8, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Liu Jing, The First Affiliated Hospital of Dalian Medical University

Tracking Information
First Submitted Date  ICMJE February 7, 2018
First Posted Date  ICMJE March 8, 2018
Last Update Posted Date March 12, 2018
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
SLEDAI-2000 score [ Time Frame: changes of month 3, month 6, month 9 and month 12 after treatment ]
The SLEDAI 2000 is a novel index that measures ≥ 50% in each of the 24 descriptors of SLEDAI-2K and generates a total score reflecting disease activity overall.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • BILAG-2004 score [ Time Frame: changes of month 3, month 6, month 9 and month 12 after treatment ]
    The BILAG-2004 is a comprehensive composite clinical index that has been recently validated for the assessment of systemic lupus erythematosus (SLE) disease activity. This index is based on the Classic BILAG index and has many similarities with its predecessor: it is based on the principle of the physician's intention to treat, has transitional property that captures changing severity of clinical manifestations and has a similar ordinal scale scoring system. However, it has nine systems and many of the changes (from the Classic BILAG index) are in the items, glossary and scoring scheme. As with the Classic BILAG index, the individual system scores were not intended to be summated into a global score.
  • Health Assessment Questionnaire (HAQ) score [ Time Frame: changes of month 3, month 6, month 9 and month 12 after treatment ]
    The Health Assessment Questionnaire (HAQ) has played an influential role in establishing health outcome assessment as a quantifiable set of reliable, valid and responsive hard data points. The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality. It has been validated by mail, in the office, by telephone, and by comparison with paraprofessional and physician judgments as a reliable instrument, and has been significantly correlated with other PRO instruments. Typically, one of two HAQ versions is used: the Full HAQ, which assesses all five dimensions, and the Short or 2-page HAQ, which contains only the HAQ disability index (HAQ-DI) and the HAQ's patient global and pain visual analog scales (VAS).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
  • BILAG-2004 score [ Time Frame: changes of month 3, month 6, month 9 and month 12 after treatment ]
    The BILAG-2004 is a comprehensive composite clinical index that has been recently validated for the assessment of systemic lupus erythematosus (SLE) disease activity.
  • Health Assessment Questionnaire (HAQ) score [ Time Frame: changes of month 3, month 6, month 9 and month 12 after treatment ]
    The Health Assessment Questionnaire (HAQ) has played an influential role in establishing health outcome assessment as a quantifiable set of reliable, valid and responsive hard data points.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Official Title  ICMJE Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Brief Summary To investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).
Detailed Description Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease. Lupus nephritis (LN) is one of the most serious complications of SLE. The current clinical treatments of LN mainly include steroids and immunosuppressive drugs, but drug side effects are obvious.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • Biological: SLE group
    The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
  • Biological: LN group
    The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
  • Other: the control group
    The patients will be assigned to the control group.
Study Arms  ICMJE
  • Experimental: SLE group
    The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
    Intervention: Biological: SLE group
  • Experimental: LN group
    The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
    Intervention: Biological: LN group
  • Experimental: the control group
    The patients will be assigned to the control group.
    Intervention: Other: the control group
Publications * Not Provided

*   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: March 1, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meeting the 1997 American College of Rheumatology (ACR) classification criteria of SLE.
  • age 18-60 years.
  • of either sex and of any ethnicity.
  • Lupus nephritis (LN) group: (1) Receiving more than 6 months of regular treatment, 24-hour urine protein ≥ 1.0 g, serum creatinine ≥1.5 mg/dL; (2) renal biopsy: class III, IV or V LN included, and class VI excluded.
  • After conventional treatment (glucocorticoid therapy and immunosuppressive drugs) prior to grouping, SLEDAI scores ≥ 10.
  • Receiving 12 months of treatment while using birth control.
  • Provision of informed consent.

Exclusion Criteria:

  • Poor blood pressure control by drug treatment (≥ 160/100 mmHg)
  • Abnormal hepatic function (a 3-fold increase in alanine aminotransferase level relative to normal liver).
  • Renal failure (glomerular filtration rate < 15 mL/min/1.73 m2).
  • Severe heart and lung failure, or injury to other important organs
  • Uncontrollable infection.
  • Having not taken biological agents for 6 months.
  • Pregnant or lactating women, or those women who are trying to get pregnant or those men who are trying to make their partners pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03458156
Other Study ID Numbers  ICMJE DalianMU_JL_002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Liu Jing, The First Affiliated Hospital of Dalian Medical University
Study Sponsor  ICMJE The First Affiliated Hospital of Dalian Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Liu Jing, Ph.D The First Affiliated Hospital of Dalian Medical University
PRS Account The First Affiliated Hospital of Dalian Medical University
Verification Date March 2018

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