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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

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ClinicalTrials.gov Identifier: NCT03055078
Recruitment Status : Unknown
Verified April 2017 by Quanhai Li, Hebei Medical University.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Quanhai Li, Hebei Medical University

Tracking Information
First Submitted Date  ICMJE February 4, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date April 7, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia
Official Title  ICMJE Evaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Brief Summary This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aplastic Anemia
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055078
Other Study ID Numbers  ICMJE 17277787D-AA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Quanhai Li, Hebei Medical University
Study Sponsor  ICMJE Hebei Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hebei Medical University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP