Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus

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

Detailed Description
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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.

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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Biological: mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of SLE(Systemic lupus erythematosus) from American College of Rheumatology(ACR) according to established criteria in 1997 Age from 14 to 60 years No serious infection or acute hemorrhage Left ventricular ejection fraction (LVEF)≥ 50% Both transaminase and serum creatinine level are more than twice times the upper limit of normal No acute infectious diseases. 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: SLE(Systemic lupus erythematosus) with severe infection. Severe heart attack, liver and kidney disease following serious complications Patients with allergic constitution. Pregnancy and breastfeeding women. Accompanied by malignant tumors or other malignant disease Patients as participant in the other clinical text Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>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<br>* 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.<br>|

What is the study measuring?
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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 |