Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001309279p
Ethics application status
Submitted, not yet approved
Date submitted
6/06/2018
Date registered
3/08/2018
Date last updated
3/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical study of umbilical cord mesenchymal stem cells in the treatment of systemic lupus erythematosus
Scientific title
Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Secondary ID [1] 295116 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune disease 308196 0
Systemic Lupus Erythematosus 308197 0
Condition category
Condition code
Inflammatory and Immune System 307233 307233 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SLE patients in the treated group were given human umbilical cord derived mesenchymal stem cells by intravenous infusion. Participants will receive a single IV infusion of Mesenchymal Stem Cells (MSCs) 1 x 10^6 cells/kg in Plasma-Lyte A solution. All patients received standard immunosuppressive treatment, which consisted of intravenous methylprednisolone and cyclophosphamide, followed by maintenance oral prednisolone and mycophenolate mofetil. All participants will receive the infusion at the Baseline (Day 0) visit. All patients after treatment for 1, 3 and 6months were evaluated respectively the curative effect.
Intervention code [1] 301450 0
Treatment: Other
Comparator / control treatment
Placebo Infusion (Plasma-Lyte A solution only)
Control group
Placebo

Outcomes
Primary outcome [1] 306186 0
To evaluate the safety of mesenchymal stem cells (MSCs) for the treatment of SLE , Toxicity of allogeneic MSC injection according to CTCAE.
Immediate tolerance as assessed after the first allogeneic MSC injection, according to standards CTCAE side effects. An injection will be considered as not tolerated for any toxicity criteria above grade greater than or equal to 3.
Timepoint [1] 306186 0
Post cell transplantation: 10 days.
Primary outcome [2] 306187 0
The change of Complement levels(C3, C4) in peripheral blood.
The recovery of immunologic function is evaluated by complement levels (g/L) in peripheral blood.
Timepoint [2] 306187 0
Post cell transplantation: 1, 3 ,6,12 months ( primary timepoint:1,3 months ).
Secondary outcome [1] 347779 0
Erythrocyte sedimentation rate.
The change of inflammation is evaluated by erythrocyte sedimentation rate.
Timepoint [1] 347779 0
Post cell transplantation: 1, 3, 6,12 months.
Secondary outcome [2] 347780 0
C-reactive protein change in SLE patients will be assessed using peripheral blood assay.
Timepoint [2] 347780 0
Post cell transplantation: 1, 3, 6,12 months
Secondary outcome [3] 347781 0
Lupus serology ( Alb, ANA, dsDNA ) change in SLE patients will be assessed using peripheral blood assay.
Timepoint [3] 347781 0
Post cell transplantation: 1, 3, 6,12 months

Eligibility
Key inclusion criteria
Diagnosis of SLE(Systemic lupus erythematosus) from American College of Rheumatology(ACR) according to established criteria in 1997.
Historical presence of at least 4 of 11 of the ACR Classification Criteria.
Evidence of a positive ANA ( greater than or equal to 1:80 titer) or positive dsDNA antibody test within 6 months of screening.
No serious infection or acute hemorrhage.
Both transaminase and serum creatinine level are more than twice times the upper limit of normal.
No acute infectious diseases.
Able and willing to give written informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
SLE(Systemic lupus erythematosus) with severe infection.
Severe heart attack, liver and kidney disease following serious complications
Patients with allergic constitution.
Pregnancy and breastfeeding women.
Accompanied by malignant tumors or other malignant disease
Patients as participant in the other clinical text
Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 10534 0
China
State/province [1] 10534 0
Inner Mongolia

Funding & Sponsors
Funding source category [1] 299696 0
Hospital
Name [1] 299696 0
Affiliated Hospital of Inner Mongolia Medical University
Country [1] 299696 0
China
Primary sponsor type
Hospital
Name
Stem Cell Centre of Affiliated Hospital of Inner Mongolia Medical University
Address
Stem Cell Centre, Affiliated Hospital of Inner Mongolia Medical University, NO.1.Tongdaobei Road, Huhhot City, Inner Mongolia Prov, China,010050.
Country
China
Secondary sponsor category [1] 299041 0
None
Name [1] 299041 0
Address [1] 299041 0
Country [1] 299041 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300597 0
Ethics committee address [1] 300597 0
Ethics committee country [1] 300597 0
Date submitted for ethics approval [1] 300597 0
20/05/2018
Approval date [1] 300597 0
Ethics approval number [1] 300597 0

Summary
Brief summary
Systemic lupus erythematosus (SLE) is a rare (prevalence: 40- 50/100 000 persons) heterogeneous auto-immune and auto-inflammatory disease (AD), affecting both sexes and all races, with a peak incidence / prevalence among black people and a predilection for women in the 3rd-4th decade of life. SLE is characterized by successive periods of flares and remission, which may all vary in duration and quality. Prognosis of severe forms of SLE, which affect lung, heart or brain in addition to renal involvement, has improved, but still evolution remains pejorative in a subset of patients whose 10 years mortality remains 10-15%, even in tertiary referral centers. For 20 years, no new prospective clinical trial in the course of SLE has demonstrated its effectiveness. New biological therapies have not yet made the long awaited breakthrough in the treatment of severe SLE and only anti-Blys monoclonal antibody has gained indication in moderately active SLE. In addition, serious adverse side effects (progressive multifocal leukoencephalopathy) observed with several biologics in AD patients has dampened their expected benefits. For SLE subjects resistant to 1er or 2nd line conventional treatment, there is a need to develop more effective therapies with fewer long term side effects, based on new immunomodulatory and immunosuppressive strategies.
According to their in vitro immunomodulatory properties and ability to induce tissue repair mechanisms, mesenchymal stem cells (MSC) have been proposed as a new therapy for several AD, including SLE. This trial will evaluate the safety of MSCs for the treatment of adults with moderate to severely active SLE.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84166 0
Prof Sheng Yun
Address 84166 0
Stem Cell Centre, Affiliated Hospital of Inner Mongolia Medical University, NO.1.Tongdaobei Road, Huhhot City, Inner Mongolia Prov, China, 010050.
Country 84166 0
China
Phone 84166 0
+86 0471 3451700
Fax 84166 0
Email 84166 0
sheng.yun@hotmail.co.uk
Contact person for public queries
Name 84167 0
Prof Sheng Yun
Address 84167 0
Stem Cell Centre, Affiliated Hospital of Inner Mongolia Medical University, NO.1.Tongdaobei Road, Huhhot City, Inner Mongolia Prov, China, 010050.
Country 84167 0
China
Phone 84167 0
+86 0471 3451700
Fax 84167 0
Email 84167 0
sheng.yun@hotmail.co.uk
Contact person for scientific queries
Name 84168 0
Prof Sheng Yun
Address 84168 0
Stem Cell Centre, Affiliated Hospital of Inner Mongolia Medical University, NO.1.Tongdaobei Road, Huhhot City, Inner Mongolia Prov, China, 010050.
Country 84168 0
China
Phone 84168 0
+86 0471 3451700
Fax 84168 0
Email 84168 0
sheng.yun@hotmail.co.uk

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Results publications and other study-related documents

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