Back to resultsUmbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SLE group
LN group
the control group
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SLE group
LN group
the control group
Arm Description
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
The patients will be assigned to the control group.
Outcomes
Primary Outcome Measures
SLEDAI-2000 score
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
BILAG-2004 score
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
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).
Full Information
NCT ID
NCT03458156
First Posted
February 7, 2018
Last Updated
March 8, 2018
Sponsor
The First Affiliated Hospital of Dalian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03458156
Brief Title
Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Official Title
Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SLE group
Arm Type
Experimental
Arm Description
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
Arm Title
LN group
Arm Type
Experimental
Arm Description
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
Arm Title
the control group
Arm Type
Experimental
Arm Description
The patients will be assigned to the control group.
Intervention Type
Biological
Intervention Name(s)
SLE group
Intervention Description
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
Intervention Type
Biological
Intervention Name(s)
LN group
Intervention Description
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
Intervention Type
Other
Intervention Name(s)
the control group
Intervention Description
The patients will be assigned to the control group.
Primary Outcome Measure Information:
Title
SLEDAI-2000 score
Description
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.
Time Frame
changes of month 3, month 6, month 9 and month 12 after treatment
Secondary Outcome Measure Information:
Title
BILAG-2004 score
Description
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.
Time Frame
changes of month 3, month 6, month 9 and month 12 after treatment
Title
Health Assessment Questionnaire (HAQ) score
Description
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).
Time Frame
changes of month 3, month 6, month 9 and month 12 after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Jing, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
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