Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lupus Nephritis
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
- Enrollment
- 30
- Primary Endpoint
- SLEDAI-2000 score
- Last Updated
- 8 years ago
Overview
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 steroids and immunosuppressive drugs, but drug side effects are obvious.
Investigators
Liu Jing
Chief Physician
The First Affiliated Hospital of Dalian Medical University
Eligibility Criteria
Inclusion Criteria
- •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 ≥
- •Receiving 12 months of treatment while using birth control.
- •Provision of informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
SLEDAI-2000 score
Time Frame: changes of month 3, month 6, month 9 and month 12 after treatment
The SLEDAI 2000 is a novel index that measures ≥ 50% in each of the 24 descriptors of SLEDAI-2K and generates a total score reflecting disease activity overall.
Secondary Outcomes
- BILAG-2004 score(changes of month 3, month 6, month 9 and month 12 after treatment)
- Health Assessment Questionnaire (HAQ) score(changes of month 3, month 6, month 9 and month 12 after treatment)