Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis

The First Affiliated Hospital of Dalian Medical University

Status: Unknown

Conditions: Lupus Nephritis

Treatments: Other: the control group; Biological: LN group; Biological: SLE group

Study type: Interventional

Funder types: Other

Identifiers

NCT03458156

DalianMU_JL_002

Details and patient eligibility

About

To investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 ≥ 10.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

SLE group

Experimental group

Description:

The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.

Treatment:

Biological: SLE group

LN group

Experimental group

Description:

The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.

Treatment:

Biological: LN group

the control group

Experimental group

Description:

The patients will be assigned to the control group.

Treatment:

Other: the control group