ClinicalTrials.gov
ClinicalTrials.gov Menu

Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

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: NCT03055078
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Quanhai Li, Hebei Medical University

Brief Summary:
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.

Condition or disease Intervention/treatment Phase
Aplastic Anemia Biological: mesenchymal stem cells Phase 1

Detailed Description:
Aplastic anemia (AA) is a disorder thought to be caused by an immune-mediated bone marrow failure. Not all people with AA are eligible for today's standard treatments. One new treatment approach uses umbilical cord derived mesenchymal stem cells—specialized cells capable of developing into other types of cells—to provide the basis for clinical application. The aim of the present study is to investigate the safety and efficacy of vein infusion of allogeneic mesenchymal stem cells in patients with AA .

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 Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mesenchymal stem cells
According to the inclusion and exclusion criteria, selected patients were divided into a cell therapy group and a control group. Umbilical cord derived mesenchymal stem cells at a dose of 100-300 million by intravenous infusion.
Biological: mesenchymal stem cells
Patients in the cell treated group were given umbilical cord derived mesenchymal stem cells by intravenous infusion besides conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1months, 3months, 6months and 9months were evaluated respectively the therapeutic effect.




Primary Outcome Measures :
  1. Hemoglobin levels in peripheral blood [ Time Frame: Post cell transplantation: 9months ]
    The recovery of bone marrow erythrocyte is evaluated by hemoglobin levels (g/L) in peripheral blood.


Secondary Outcome Measures :
  1. The number of red blood cell in peripheral blood [ Time Frame: Post cell transplantation: 1, 3, 6, 9months ]
    The improvement of bone marrow erythrocyte is evaluated by red blood cell count (×10^12/L) in peripheral blood.

  2. The number of granulocyte in peripheral blood [ Time Frame: Post cell transplantation: 1, 3, 6, 9months ]
    The recovery of bone marrow granulocyte is evaluated by granulocyte count (×10^9/L) in peripheral blood.

  3. The number of white blood cell in peripheral blood [ Time Frame: Post cell transplantation: 1, 3, 6, 9months ]
    The improvement of bone marrow granulocyte is evaluated by white blood cell count (×10^9/L) in peripheral blood.

  4. The evaluation of bone marrow megakaryocytic series [ Time Frame: Post cell transplantation: 1, 3, 6, 9months ]
    The status of megakaryocytic series is evaluated by platelet count (×10^9/L) in peripheral blood.

  5. adverse reaction [ Time Frame: Post cell transplantation: 1, 3, 6, 9months ]
    Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction.



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 AA according to established criteria in 2010
  2. Age from 14 to 60 years
  3. Suffering from AA within six months
  4. No serious infection or acute hemorrhage.
  5. Left ventricular ejection fraction (LVEF) ≥ 50%
  6. No acute infectious diseases.
  7. Understanding and willingness to sign a written informed consent document.
  8. Eastern Cooperative Oncology Group(ECOG) score of 0-2pionts.

Exclusion Criteria:

- Patients with AA have to be disqualified from this study if any of the following is applicable.

  1. Severe aplastic anemia(SAA) with severe infection.
  2. Severe aplastic anemia(SAA) with active hemorrhage.
  3. Severe heart attack, liver and kidney disease following serious complications
  4. Patients with allergic constitution.
  5. Pregnancy and lactation.
  6. Accompanied by malignant tumors and other clonal disease.
  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): NCT03055078


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

Locations
China, Hebei
the First Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050031
Contact: Jun Zhang, Master    86-311-85917384    june_luck@126.com   
Sponsors and Collaborators
Hebei Medical University
Investigators
Study Chair: Baoyong Yan, Doctor The First Hospital of Hebei Medical University
Study Director: Qingchi 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: NCT03055078     History of Changes
Other Study ID Numbers: 17277787D-AA
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases