Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03219801
• Other study ID #: 17277787D-SLE
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: July 10, 2017
• Last updated: July 13, 2017
• Start date: August 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2017
• Source: Hebei Medical University
• Contact: Jun Zhang, Master
• Phone: 86-311-85917384
• Email: june_luck[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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.

Locations

Country	Name	City	State
China	the First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Erythrocyte sedimentation rate	The change of inflammation is evaluated by erythrocyte sedimentation rate.	Post cell transplantation: 1, 3, 6 months
Secondary	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
Secondary	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