Clinical trial NCT03219801: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change of Complement levels(C3 and C4) in peripheral blood
timeFrame: Post cell transplantation: 1, 3, 6 months
Secondary outcomes:
measure: Erythrocyte sedimentation rate
timeFrame: Post cell transplantation: 1, 3, 6 months
measure: C-reactive protein
timeFrame: Post cell transplantation: 1, 3, 6 months
measure: adverse reaction
timeFrame: Post cell transplantation: 1, 3, 6 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Baoyong Yan, Doctor
role: STUDY_CHAIR
affiliation: The First Hospital of Hebei Medical University
name: Qingchi Liu Liu, Doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Quanhai Li, Doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Xiaohui Jia, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Xianyun Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Fan Zhang, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Yang Shen, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Bing Ma, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Wanyi Yin, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Dan Zhao, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Bojian Sun, Master
role: PRINCIPAL_INVESTIGATOR
References: