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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01741857 |
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Date of registration:
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26/11/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus
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Scientific title:
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Phase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus Erythematosus |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01741857 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Sun |
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Address:
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Telephone:
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+86-25-83105209 |
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Email:
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Affiliation:
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Name:
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Lingyun Sun, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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the Affiliated Drum Tower Hospital of Nanjing University Medical School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE,
man or woman aged from 15 to 60 years old, SLEDAI=8;
- Lupus nephritis with 24h urine protein=1g;
- Refractory disease as determined by failure of the following regimens:
Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide
0.4 ~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as
mycophenolate mofetil 2 g / day, for three months;
- Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policy of the hospital;
- Willing to use contraception throughout the study and for 12 months following
treatment
Exclusion Criteria:
- Abnormal liver function (ALT higher than 3 times the normal value);
- End-stage renal failure;
- Severe heart and pulmonary failure, or other important organs damage;
- Uncontrolled infections
- Pregnant or breast feeding women, male or female who intended to recent pregnancy
Age minimum:
15 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Biological: human umbilical cord derived MSC transplantation for SLE
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Primary Outcome(s)
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British Isles Lupus Assessment Group score (BILAG)
[Time Frame: up to 12 months]
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Secondary Outcome(s)
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Renal function (GFR, Blood Urea Nitrogen, urinalysis)
[Time Frame: pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation (for GFR assessed at baseline and 12 months after MSCT)]
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Lupus serology (Alb, ANA, dsDNA, C3, C4)
[Time Frame: pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation]
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Secondary ID(s)
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NJGLYY005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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