Status:
UNKNOWN
Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Lead Sponsor:
The First Affiliated Hospital of Dalian Medical University
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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).
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 stero...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03458156
Start Date
January 1 2017
End Date
January 1 2020
Last Update
March 12 2018
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