Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03458156
• Other study ID #: DalianMU_JL_002
• Status: Active, not recruiting
• Phase: N/A
• First received: February 7, 2018
• Last updated: March 8, 2018
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: March 2018
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

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

Other:
• the control group
The patients will be assigned to the control group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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