Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis

Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis

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

Study Overview

• Status: Unknown
• Conditions: Lupus Nephritis
• Intervention / Treatment: Biological: SLE group; Biological: LN group; Other: the control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SLE group; The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.	Biological: SLE group; The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
Experimental: LN group; The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.	Biological: LN group; The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
Experimental: the control group; The patients will be assigned to the control group.	Other: the control group; The patients will be assigned to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLEDAI-2000 score	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.	changes of month 3, month 6, month 9 and month 12 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BILAG-2004 score	The BILAG-2004 is a comprehensive composite clinical index that has been recently validated for the assessment of systemic lupus erythematosus (SLE) disease activity. This index is based on the Classic BILAG index and has many similarities with its predecessor: it is based on the principle of the physician's intention to treat, has transitional property that captures changing severity of clinical manifestations and has a similar ordinal scale scoring system. However, it has nine systems and many of the changes (from the Classic BILAG index) are in the items, glossary and scoring scheme. As with the Classic BILAG index, the individual system scores were not intended to be summated into a global score.	changes of month 3, month 6, month 9 and month 12 after treatment
Health Assessment Questionnaire (HAQ) score	The Health Assessment Questionnaire (HAQ) has played an influential role in establishing health outcome assessment as a quantifiable set of reliable, valid and responsive hard data points. The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality. It has been validated by mail, in the office, by telephone, and by comparison with paraprofessional and physician judgments as a reliable instrument, and has been significantly correlated with other PRO instruments. Typically, one of two HAQ versions is used: the Full HAQ, which assesses all five dimensions, and the Short or 2-page HAQ, which contains only the HAQ disability index (HAQ-DI) and the HAQ's patient global and pain visual analog scales (VAS).	changes of month 3, month 6, month 9 and month 12 after treatment

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University
• Investigators: Principal Investigator: Liu Jing, Ph.D, The First Affiliated Hospital of Dalian Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis
• Other Study ID Numbers: DalianMU_JL_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED