ClinicalTrials.gov
ClinicalTrials.gov Menu

Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03219801
Recruitment Status : Not yet recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Quanhai Li, Hebei Medical University

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: mesenchymal stem cells Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: mesenchymal stem cells
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.
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.




Primary Outcome Measures :
  1. The change of Complement levels(C3 and C4) in peripheral blood [ Time Frame: Post cell transplantation: 1, 3, 6 months ]
    The recovery of immunologic function is evaluated by complement levels (g/L) in peripheral blood.


Secondary Outcome Measures :
  1. Erythrocyte sedimentation rate [ Time Frame: Post cell transplantation: 1, 3, 6 months ]
    The change of inflammation is evaluated by erythrocyte sedimentation rate.

  2. C-reactive protein [ Time Frame: Post cell transplantation: 1, 3, 6 months ]
    C-reactive protein is an acute phase reactants. It can be moderately increased in in peripheral blood of SLE patients.

  3. adverse reaction [ Time Frame: Post cell transplantation: 1, 3, 6 months ]
    Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction.These measurements were associated with the safety of the intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219801


Contacts
Contact: Jun Zhang, Master 86-311-85917384 june_luck@126.com

Locations
China, Hebei
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Sponsors and Collaborators
Hebei Medical University
Investigators
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

Responsible Party: Quanhai Li, Director of Cell Thearpy Center, the First Hospital of HeibeiMU, Hebei Medical University
ClinicalTrials.gov Identifier: NCT03219801     History of Changes
Other Study ID Numbers: 17277787D-SLE
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases