Lupus NephritisNCT03458156
Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
A study testing SLE group and LN group in people with Lupus Nephritis, run by The First Affiliated Hospital of Dalian Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- SLE group and LN group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
To investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).
Read the 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.
- Conditions
- Lupus Nephritis
- Being tested
- SLE group, LN group, the control group
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLE groupBiological
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
LN groupBiological
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
the control groupOther
The patients will be assigned to the control group.
| Study group | Role | What they receive |
|---|---|---|
| SLE group | Experimental | The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation. Receives: Biological: SLE group |
| LN group | Experimental | The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation. Receives: Biological: LN group |
| the control group | Experimental | The patients will be assigned to the control group. Receives: Other: the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: changes of month 3, month 6, month 9 and month 12 after treatment
Secondary outcomes (2)
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.
Measured: changes of month 3, month 6, month 9 and month 12 after treatment
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).
Measured: changes of month 3, month 6, month 9 and month 12 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study startJan 2017
- Primary completionSep 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Jing, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Liu Jing, Ph.D, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458156
- Sponsor's protocol ID
- DalianMU_JL_002
- Status last verified
- Mar 2018
- First submitted
- 7 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
- ClinicalTrials.gov ID
- NCT03458156
- Acronym / sponsor ID
- DalianMU_JL_002
- Conditions
- Lupus Nephritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLE group | Experimental | Biological: SLE groupThe patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation. |
| LN group | Experimental | Biological: LN groupThe patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation. |
| the control group | Experimental | Other: the control groupThe patients will be assigned to the control group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLE groupThe patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation. | Biological | SLE group |
| LN groupThe patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation. | Biological | LN group |
| the control groupThe patients will be assigned to the control group. | Other | the control group |
Primary outcome
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.
2 secondary outcomes
BILAG-2004 score
Time frame: changes of month 3, month 6, month 9 and month 12 after treatment
Health Assessment Questionnaire (HAQ) score
Time frame: changes of month 3, month 6, month 9 and month 12 after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Jing, Ph.D principal investigator
The First Affiliated Hospital of Dalian Medical University
Questions about this trial
What is this clinical trial studying?
A study testing SLE group and LN group in people with Lupus Nephritis, run by The First Affiliated Hospital of Dalian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLEDAI-2000 score (time frame: changes of month 3, month 6, month 9 and month 12 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.