Lupus NephritisPhase 2hUC-MSC-SLENCT01539902
Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
A Phase 2 study testing Human Umbilical Cord derived MSCs and Cyclophosphamide in people with Lupus Nephritis, run by CytoMed & Beike at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Human Umbilical Cord derived MSCs and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to May 2013
- Phase
- Phase 2
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or non-pregnant females age 16 to 65 years inclusive.
- Written informed consent obtained from patient or parents/guardian.
- Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
- Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis
Who cannot join
- Patients with any of the following are not eligible for enrollment into the study:
- 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.
- Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
- Those persons directly involved in the conduct of the study.
- Serum creatinine more than 250 µmol/L.
- White blood cell (WBC) count of less than 3.5 X 109/L.
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- Active peptic ulcer disease.
- Active systemic infection.
- History of alcohol or substance abuse.
- History of malignancy within previous 5 years.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China
Kunming, Yunan, 650000
PeiLian Zhang, Dr, mzczpl1968@163.com
DanQi Deng, Professor
About this study
Official title: A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
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.
Read the detailed description
Inclusion criteria:
- Male or non-pregnant females age 16 to 65 years inclusive.
- Written informed consent obtained from patient or parents/guardian.
- Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
- Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.
- Conditions
- Lupus Nephritis
- Being tested
- Human Umbilical Cord derived MSCs, Cyclophosphamide
- Keywords
- MSC for the treatment of Lupus Nephritis
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Umbilical Cord derived MSCsBiological
Also called Allogeneic stem cells derived from umbilical cord
Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion
CyclophosphamideDrug
Also called Immunosupressive agent
Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
| Study group | Role | What they receive |
|---|---|---|
| Human Umbilical Cord derived MSCs | Experimental | Not described Receives: Biological: Human Umbilical Cord derived MSCs |
| Cyclophosphamide | Placebo comparator | Not described Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Safety
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytoMed & Beike
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539902
- Sponsor's protocol ID
- CT 11-03
- Acronym
- hUC-MSC-SLE
- Status last verified
- Mar 2012
- First submitted
- 22 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28478399
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01539902
- Acronym / sponsor ID
- hUC-MSC-SLE / CT 11-03
- Conditions
- Lupus Nephritis
- Keywords
- MSC for the treatment of Lupus Nephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- CytoMed & BeikeUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 28 Feb 2012 (estimated)
- 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.
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:
- Male or non-pregnant females age 16 to 65 years inclusive.
- Written informed consent obtained from patient or parents/guardian.
- Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
- Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Umbilical Cord derived MSCs | Experimental | Biological: Human Umbilical Cord derived MSCs |
| Cyclophosphamide | Placebo comparator | Drug: Cyclophosphamide |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant females age 16 to 65 years inclusive.
- Written informed consent obtained from patient or parents/guardian.
- Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
- Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis
Key exclusion criteria (11 listed)
- 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.
- Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
- Those persons directly involved in the conduct of the study.
- Serum creatinine more than 250 µmol/L.
- White blood cell (WBC) count of less than 3.5 X 109/L.
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 |
|---|---|---|
| Human Umbilical Cord derived MSCsAlso: Allogeneic stem cells derived from umbilical cordHuman Umbilical Cord derived MSCs treatment for lupus nephritis via infusion | Biological | Human Umbilical Cord derived MSCs |
| CyclophosphamideAlso: Immunosupressive agentCyclophosphamide based immunosuppressive agent for treatment for lupus nephritis | Drug | Cyclophosphamide |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Derived from this study: PubMed 28478399Deng 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.
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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.
Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China
Kunming, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Umbilical Cord derived MSCs and Cyclophosphamide in people with Lupus Nephritis, run by CytoMed & Beike at 1 site in China.
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 4 inclusion and 11 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 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and Safety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01539902, which also lists 1 linked publication.
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 6 Mar 2012; AzTrials last refreshed its copy on 6 Nov 2026.