Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus

Early Phase 1UnknownNCT03219801

Hebei Medical University10 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

mesenchymal stem cellsBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Outcomes

Primary Outcomes

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.

Time frame: Post cell transplantation: 1, 3, 6 months

Secondary Outcomes

Erythrocyte sedimentation rate

The change of inflammation is evaluated by erythrocyte sedimentation rate.

Time frame: 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.

Time frame: 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.

Time frame: Post cell transplantation: 1, 3, 6 months

Central Contacts

Jun Zhang, Master

CONTACT

86-311-85917384 june_luck@126.com

Data from ClinicalTrials.gov

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