Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cells | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Erythrocyte sedimentation rate | The change of inflammation is evaluated by erythrocyte sedimentation rate. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with SLE have to be disqualified from this study if any of the following is applicable:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhang, Master | Contact | 86-311-85917384 | june_luck@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Baoyong Yan, Doctor | The First Hospital of Hebei Medical University | Study Chair |
| Qingchi Liu Liu, Doctor | The First Hospital of Hebei Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050031 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | Post cell transplantation: 1, 3, 6 months |
| Quanhai Li, Doctor |
| The First Hospital of Hebei Medical University |
| Study Director |
| 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 | Principal Investigator |