A Prospective, Single-center Study of Comparing the Efficacy and Safety of Human Umbilical Cord Mesenchymal Stem Cells and Low-dose IL-2 in the Treatment of Lupus Nephritis

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare the efficacy and safety of human umbilical cord mesenchymal stem cells and low-dose IL-2 in the treatment of LN

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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⁃ Only patients with active lupus nephritis who meet all of the following criteria are eligible for inclusion in this study:

• Before random assignment, records show that it meets at least 4 of the 11 SLE classification criteria recommended by ACR in 1997.

• Age: age \> 18 years old, ≤ 65 years old when obtaining informed consent

• SLEDAI-2K score ≥ 6

• Urinary total protein / creatinine ratio \> 1.0 or 24-hour urinary protein \> 1.0g, with or without microscopic hematuria

• If they are fertile, they must agree to use effective contraception during the trial.

• In the case of women of childbearing age, urinary pregnancy and serum pregnancy tests should be negative.

• Voluntarily sign informed consent and comply with the requirements of the research programme

Locations
Other Locations
China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Contact Information
Primary
Jun Liang, Doctor
13505193169@139.com
13505193169
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: MSCs group
In this group, patients will receive intravenous injection of human umbilical cord mesenchymal stem cells (2 × 10\^6 cells / kg body weight, suspended in 30ml saline)
Experimental: IL-2 group
In this group, patients will receive subcutaneous injection of IL-2 (1×10\^6IU) every other day for 2 weeks (7 times), with an interval of 2 weeks.
Sponsors
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov