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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Nanfang Hospital of Southern Medical University
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 Municipal People’s Hospital
Guangdong Provincial People's Hospital
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01763086
First received: January 5, 2013
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Stem Cell Transplantation, Hematopoietic
Mesenchymal Stem Cells
Poor Graft Function
Hematological Diseases
Biological: Mesenchymal stem cells
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells From Third-party Donors for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • hematopoietic recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • infections, primary underlying disease relapse and any toxic side effects of MSCs treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal stem cells
Mesenchymal stem cells 1×10^6 cells/kg, intravenously
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763086

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

Locations
China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ren Lin, MD    +86-020-61641613    lansinglinren@hotmail.com   
Principal Investigator: Qifa Liu, MD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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 Municipal People’s Hospital
Guangdong Provincial People's Hospital
Investigators
Principal Investigator: Qifa Liu, MD Nanfang Hospital of Southern Medical University
  More Information

Publications:
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01763086     History of Changes
Other Study ID Numbers: NFH-MSC-allo-HSCT-2013
Study First Received: January 5, 2013
Last Updated: January 15, 2013
Health Authority: China: Ethics Committee

Keywords provided by Nanfang Hospital of Southern Medical University:
Poor Graft Function
Mesenchymal Stem Cells
Allogeneic hematopoietic stem cell transplantation
Third-party Donors

Additional relevant MeSH terms:
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014