Back to resultsPhase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis (hUC-MSC-SLE)
Primary Purpose
Lupus Nephritis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Human Umbilical Cord derived MSCs
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring MSC for the treatment of Lupus Nephritis
Eligibility Criteria
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
Exclusion Criteria:
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.
- 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.
Sites / Locations
- Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Human Umbilical Cord derived MSCs
Cyclophosphamide
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01539902
Brief Title
Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
Acronym
hUC-MSC-SLE
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoMed & Beike
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
MSC for the treatment of Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Human Umbilical Cord derived MSCs
Arm Type
Experimental
Arm Title
Cyclophosphamide
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Human Umbilical Cord derived MSCs
Other Intervention Name(s)
Allogeneic stem cells derived from umbilical cord
Intervention Description
Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Immunosupressive agent
Intervention Description
Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
Primary Outcome Measure Information:
Title
Efficacy and Safety
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China
City
Kunming
State/Province
Yunan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PeiLian Zhang, Dr
Email
mzczpl1968@163.com
First Name & Middle Initial & Last Name & Degree
DanQi Deng, Professor
First Name & Middle Initial & Last Name & Degree
PeiLian Zhang, Dr
12. IPD Sharing Statement
Citations:
PubMed Identifier
28478399
Citation
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.
Results Reference
derived
Learn more about this trial
Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
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