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Trial record 46 of 907 for:    Lupus

Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT03458156
Recruitment Status : 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

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).

Condition or disease Intervention/treatment Phase
Lupus Nephritis Biological: SLE group Biological: LN group Other: the control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Study Start Date : January 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

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Arm Intervention/treatment
Experimental: SLE group
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
Biological: SLE group
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.

Experimental: LN group
The patients will be assigned to lupus nephritis (LN) 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.

Experimental: the control group
The patients will be assigned to the control group.
Other: the control group
The patients will be assigned to the control group.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03458156


Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Investigators
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Principal Investigator: Liu Jing, Ph.D The First Affiliated Hospital of Dalian Medical University

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Responsible Party: Liu Jing, Chief Physician, The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT03458156     History of Changes
Other Study ID Numbers: DalianMU_JL_002
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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