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Peripheral Blood Stem Cell Combined With Mesenchymal Stem Cells for Treatment of Poor Graft Function

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ClinicalTrials.gov Identifier: NCT02083718
Recruitment Status : Unknown
Verified March 2014 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Collaborators:
Academy Military Medical Science, China
Peking University People's Hospital
Sun Yat-sen University
Guangdong General Hospital
Guangzhou General Hospital of Guangzhou Military Command
Third Affiliated Hospital, Sun Yat-Sen University
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Brief Summary:
The purpose of this study is to evaluate the utility of treating patients experiencing poor graft function after allogeneic hematopoietic stem cell transplantation with Granulocyte Colony-Stimulating Factor (G-CSF) mobilized peripheral stem cell combined (PBSC) with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. Our first objective was to evaluate the effect of such treatment on poor graft function, and second object was to investigate the safety of such treatment.

Condition or disease Intervention/treatment Phase
Stem Cell Transplantation, Hematopoietic Poor Graft Function Hematological Diseases Biological: PBSC Biological: MSCs Phase 2

Detailed Description:

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) is the only cure for many hematologic diseases. However, poor graft function (PGF) is an important complication after allo-HSCT that occurs in 5-27% of patients, and is associated with considerable mortality related to infections or hemorrhagic complications. Treatment of PGF usually involves the prescription of hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF), or second transplantation, but these methods are associated with dismal effect or even a significant risk of graft-versus-host disease (GVHD).

Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs include improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. Some studies have shown that MSCs combined with PBSC or cord blood could be useful to improve engraftment after HSCT. Several reports suggested MSCs might be effective in the treatment of PGF.

However, the efficacy of MSCs as single-drug treatment for PGF is unsatisfactory in our previous study. Therefore, in the present study, G-CSF mobilized PBSC will be used combined with MSCs in the patients with PGF after allo-HSCT.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: G-CSF Mobilized Peripheral Blood Stem Cell Combined With Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplant
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: PBSC & MSCs
PBSC will be intravenously infused at a dose of 2×10^8/kg. MSCs will be intravenously infused at a dose of 1×10^6 cells/kg once per week. The vital signs of all patients will be closely monitored during and for 24h after administration.If the NEU and PLT levels do not attain the completely response(CR)standards within 28d, a second course of the same treatment will be given.
Biological: PBSC
Biological: MSCs



Primary Outcome Measures :
  1. Percentage of Participants with Hematopoietic Recovery [ Time Frame: 1 year ]
    Hematopoietic reconstitution post-transplantation is defined as reconstitution of both neutrophil and platelet numbers. Neutrophil reconstitution is defined as occurring on the first 3 consecutive days with an neutrophil(NEU)>0.5×10^9/L, and platelet (PLT) reconstitution is defined as the first >20×10^9/L for 3 consecutive days.


Secondary Outcome Measures :
  1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: up to 1 year ]
    Adverse Events include infections, GVHD, primary underlying disease relapse and any other side effects. Infections will be mainly focused within the first 100 days after treatment. Side effects of treatment includes acute toxicity and late side effects. Acute toxicity principally involves the heart,live and kidney. Late toxic side effects involves principally the development of secondary tumors and relapse of the primary disease.



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A patient age of 14-65 years
  • Poor graft function developing after allo-HSCT
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

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): NCT02083718


Contacts
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Contact: Ren Lin, MD. +86-020-61641613 lansinglinren@hotmail.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ren Lin    +86-020-61641613    lansinglinren@hotmail.com   
Principal Investigator: Qifa Liu         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Academy Military Medical Science, China
Peking University People's Hospital
Sun Yat-sen University
Guangdong General Hospital
Guangzhou General Hospital of Guangzhou Military Command
Third Affiliated Hospital, Sun Yat-Sen University
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Qifa Liu, MD. Nanfang Hospital of Southern Medical University

Publications:
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02083718     History of Changes
Other Study ID Numbers: NFH-PBSC-MSC-2014
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Qifa Liu, Nanfang Hospital of Southern Medical University:
Poor Graft Function
Peripheral Blood Stem Cell
Mesenchymal Stem Cells
Allogeneic hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Hematologic Diseases