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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

mesenchymal stem cells

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

the First Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mesenchymal stem cells

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Erythrocyte sedimentation rate

The change of inflammation is evaluated by erythrocyte sedimentation rate.

C-reactive protein

C-reactive protein is an acute phase reactants. It can be moderately increased in in peripheral blood of SLE patients.

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.

Full Information

NCT ID

NCT03219801

First Posted

July 10, 2017

Last Updated

July 13, 2017

Sponsor

Hebei Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03219801

Brief Title

Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2017 (Anticipated)

Primary Completion Date

December 30, 2018 (Anticipated)

Study Completion Date

December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mesenchymal stem cells

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

mesenchymal stem cells

Intervention Description

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.

Primary Outcome Measure Information:

Title

The change of Complement levels(C3 and C4) in peripheral blood

Description

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 Outcome Measure Information:

Title

Erythrocyte sedimentation rate

Description

The change of inflammation is evaluated by erythrocyte sedimentation rate.

Time Frame

Post cell transplantation: 1, 3, 6 months

Title

C-reactive protein

Description

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

Title

adverse reaction

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Zhang, Master

Phone

86-311-85917384

june_luck@126.com

Overall Study Officials: