Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus
Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
1 other identifier
interventional
10
1 country
1
Brief Summary
This study is to evaluate the safety and efficacy of human umbilical cord derived mesenchymal stem cells transplantation in systemic lupus erythematosus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Aug 2017
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedJuly 18, 2017
July 1, 2017
1.4 years
July 10, 2017
July 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Erythrocyte sedimentation rate
Post cell transplantation: 1, 3, 6 months
C-reactive protein
Post cell transplantation: 1, 3, 6 months
adverse reaction
Post cell transplantation: 1, 3, 6 months
Study Arms (1)
mesenchymal stem cells
EXPERIMENTALSelected 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.
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Baoyong Yan, Doctor
The First Hospital of Hebei Medical University
- STUDY DIRECTOR
Qingchi Liu Liu, Doctor
The First Hospital of Hebei Medical University
- STUDY DIRECTOR
Quanhai Li, Doctor
The First Hospital of Hebei Medical University
- PRINCIPAL INVESTIGATOR
Xiaohui Jia, Doctor
The First Hospital of Hebei Medical University
- PRINCIPAL INVESTIGATOR
Xianyun Wang, Doctor
The First Hospital of Hebei Medical University
- PRINCIPAL INVESTIGATOR
Fan Zhang, Bachelor
The First Hospital of Hebei Medical University
- PRINCIPAL INVESTIGATOR
Yang Shen, Master
The First Hospital of Hebei Medical University
- PRINCIPAL INVESTIGATOR
Bing Ma, Master
The First Hospital of Hebei Medical University
- PRINCIPAL INVESTIGATOR
Wanyi Yin, Master
The First Hospital of Hebei Medical University
- PRINCIPAL INVESTIGATOR
Dan Zhao, Master
The First Hospital of Hebei Medical University
- PRINCIPAL INVESTIGATOR
Bojian Sun, Master
The First Hospital of Hebei Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Study Record Dates
First Submitted
July 10, 2017
First Posted
July 18, 2017
Study Start
August 1, 2017
Primary Completion
December 30, 2018
Study Completion
December 30, 2019
Last Updated
July 18, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share