Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus

Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells

This study is to evaluate the safety and efficacy of human umbilical cord derived mesenchymal stem cells transplantation in systemic lupus erythematosus.

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: mesenchymal stem cells

Detailed Description

To ensure that all patients of systemic lupus erythematosus (SLE) completed 6-months follow-up, twenty SLE patients ranging from 14 to 60 years old were enrolled in this trial. Participants matched with the inclusion criteria were allocated randomly into two groups:Human Umbilical Cord Derived Mesenchymal Stem Cells (hUC-MSCs) treated group and control group. Clinical trials are being increasingly established to investigate the therapeutic potential of these cells for SLE. The aim of the present study is to investigate safety and efficacy of vein infusion of allogeneic hUC-MSCs in patients with SLE.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050031
      • The First Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of SLE(Systemic lupus erythematosus) from American College of Rheumatology(ACR) according to established criteria in 1997
2. Age from 14 to 60 years
3. No serious infection or acute hemorrhage
4. Left ventricular ejection fraction (LVEF)≥ 50%
5. Both transaminase and serum creatinine level are more than twice times the upper limit of normal
6. No acute infectious diseases.
7. Understanding and willingness to sign a written informed consent document.

Exclusion Criteria:

Patients with SLE have to be disqualified from this study if any of the following is applicable:

1. SLE(Systemic lupus erythematosus) with severe infection.
2. Severe heart attack, liver and kidney disease following serious complications
3. Patients with allergic constitution.
4. Pregnancy and breastfeeding women.
5. Accompanied by malignant tumors or other malignant disease
6. Patients as participant in the other clinical text
7. Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: mesenchymal stem cells; Selected SLE patients were randomly divided into treated group and control group. In the treated group, 100-300 million allogeneic human umbilical cord derived mesenchymal stem cells were infused intravenously for one SLE patient. The possible adverse events, including immediately after mesenchymal stem cells infusions, as well as the long-term safety profiles were observed.

Biological: mesenchymal stem cells; SLE patients in the treated group were given human umbilical cord derived mesenchymal stem cells by intravenous infusion and conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1, 3 and 6months were evaluated respectively the curative effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Complement levels(C3 and C4) in peripheral blood	The recovery of immunologic function is evaluated by complement levels (g/L) in peripheral blood.	Post cell transplantation: 1, 3, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythrocyte sedimentation rate	The change of inflammation is evaluated by erythrocyte sedimentation rate.	Post cell transplantation: 1, 3, 6 months
C-reactive protein	C-reactive protein is an acute phase reactants. It can be moderately increased in in peripheral blood of SLE patients.	Post cell transplantation: 1, 3, 6 months
adverse reaction	Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction.These measurements were associated with the safety of the intervention.	Post cell transplantation: 1, 3, 6 months

Collaborators and Investigators

• Sponsor: Hebei Medical University
• Investigators: Study Director: Quanhai Li, Doctor, The First Hospital of Hebei Medical University; Principal Investigator: Xianyun Wang, Doctor, The First Hospital of Hebei Medical University; Principal Investigator: Fan Zhang, Bachelor, The First Hospital of Hebei Medical University; Study Director: Qingchi Liu Liu, Doctor, The First Hospital of Hebei Medical University; Principal Investigator: Xiaohui Jia, Doctor, The First Hospital of Hebei Medical University; Principal Investigator: Yang Shen, Master, The First Hospital of Hebei Medical University; Principal Investigator: Bing Ma, Master, The First Hospital of Hebei Medical University; Principal Investigator: Wanyi Yin, Master, The First Hospital of Hebei Medical University; Principal Investigator: Dan Zhao, Master, The First Hospital of Hebei Medical University; Principal Investigator: Bojian Sun, Master, The First Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 17277787D-SLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No