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Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT01763086
Recruitment Status : Unknown
Verified January 2013 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : January 8, 2013
Last Update Posted : January 16, 2013
Sponsor:
Collaborators:
Peking University People's Hospital
Sun Yat-sen University
Guangdong General Hospital
Guangzhou General Hospital of Guangzhou Military Command
Southern Medical University, China
Third Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Zhongshan People's Hospital, Guangdong, China
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE January 5, 2013
First Posted Date  ICMJE January 8, 2013
Last Update Posted Date January 16, 2013
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01763086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2013)
infections, primary underlying disease relapse and any toxic side effects of MSCs treatment [ Time Frame: 1 year ]
Infections will be mainly focused within the first 100 days after MSCs treatment. Toxic 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.
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 Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplant
Official Title  ICMJE Mesenchymal Stem Cells From Third-party Donors for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
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 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.
Detailed Description

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although good progress has been made in the prevention and treatment of side effects associated with transplantation, poor graft function (PGF) remains an important complication that occurs in 5-27% of patients, and is associated with considerable morbidity and 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 repeat transplantation, but these methods are associated with short-term effect and a significant risk of graft-versus-host disease(GVHD) development, respectively.

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 are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. However, the efficacy of treatment of PGF that develops after allo-HSCT using expanded BM-derived MSCs from a third-party donor is rarely reported. If such treatment could be shown to be effective and safe, BM-derived MSCs could potentially be used as an universal donor material. This would have a major impact because the generation of donor-specific MSCs is time-consuming, costly, and often impractical if the clinical status of a patient is urgent.

In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors in treating patients with PGF after allo-HSCT.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stem Cell Transplantation, Hematopoietic
  • Mesenchymal Stem Cells
  • Poor Graft Function
  • Hematological Diseases
Intervention  ICMJE Biological: Mesenchymal stem cells
Mesenchymal stem cells will be intravenously infused via a central venous catheter,at a dose of 1×10^6 cells/kg, over 15 min. The vital signs of all patients will be closely monitored during and for 24h after MSCs administration. If the NEU and PLT levels do not attain the completely response(CR)standards within 14d, a second course of MSCs treatment will be given.
Study Arms  ICMJE Experimental: Mesenchymal stem cells
Mesenchymal stem cells 1×10^6 cells/kg, intravenously
Intervention: Biological: Mesenchymal stem cells
Publications *

*   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: January 5, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older 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 NCT01763086
Other Study ID Numbers  ICMJE NFH-MSC-allo-HSCT-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE
  • Peking University People's Hospital
  • Sun Yat-sen University
  • Guangdong General Hospital
  • Guangzhou General Hospital of Guangzhou Military Command
  • Southern Medical University, China
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Guangzhou First People's Hospital
  • Zhongshan People's Hospital, Guangdong, China
Investigators  ICMJE
Principal Investigator: Qifa Liu, MD Nanfang Hospital of Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date January 2013

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