Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus

Early Phase 1

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: mesenchymal stem cells

• Registration Number: NCT03219801
• Lead Sponsor: Hebei Medical University

Brief Summary

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

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 Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-13
• Last Update Submitted: 2017-07-13
• Study First Posted: 2017-07-18
• Last Update Posted: 2017-07-18
• Study Start: 2017-08-01
• Primary Completion: 2018-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cells	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

the First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China