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Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure

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ClinicalTrials.gov Identifier: NCT01763099
Recruitment Status : Unknown
Verified January 2013 by Nanfang Hospital, 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 Provincial People's 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, Southern Medical University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the utility of treating patients experiencing graft failure after autologous hematopoietic stem cell transplantation with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors or mesenchymal stem cells combined with cord blood. The first objective of this study was to evaluate the effect of such treatment on graft failure, and second object was to investigate the safety of such treatment.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Mesenchymal Stem Cells Umbilical Cord Blood Graft Failure Hematological Diseases Biological: Mesenchymal stem cells Biological: Mesenchymal stem cells and cord blood Phase 2

Detailed Description:

Autologous hematopoietic stem cell transplantation (auto-HSCT) are considered the standard of care for many malignancies, such as lymphoma, myeloma and some leukemias, and so on. Graft failure after auto-HSCT is a formidable complication. It occurs in 2-9.5% of patients and is associated with considerable morbidity and mortality related to infections and hemorrhagic complications. There are various options for the management of graft failure. The most common treatment of graft failure is growth factors such as granulocyte colony-stimulating factor (G-CSF)and recombinant erythropoietin,but it usually effective in the short term and no effect on platelet counts.

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 (GVHD) after allogeneic hematopoietic stem cell transplantation and so on.As an important source of hematopoietic stem cell, cord blood has been widely used in clinical practice. It is reported that cord blood combined with MSCs can increase engraftment after allogeneic hematopoietic stem cell transplantation. However, to our knowledge, the report about efficacy of treatment of graft that develops after auto-HSCT using expanded BM-derived MSCs from a third-party donor combined with cord blood is absent.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 or MSCs combined with cord blood in treating patients with graft failure after auto-HSCT.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure Following Autologous Hematopoietic Stem Cell Transplantation
Study Start Date : January 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal stem cells
Mesenchymal stem cells group refers to treatment with 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) in day 1 and day 15 of the cycle. If the NEU and PLT levels do not attain the completely response(CR)standards after this cycle, mesenchymal stem cells combined with cord blood will be given. If the NEU and PLT levels attain the completely response(CR)or partly response(PR) standards after this cycle, another cycle with the same strategy will be given.
Experimental: Mesenchymal stem cells and cord blood
Mesenchymal stem cells and cord blood group refers to treatment with mesenchymal stem cells (at a dose of 1×10^6 cells/kg) and cord blood
 Biological: Mesenchymal stem cells and cord blood
Mesenchymal stem cells will be given (at a dose of 1×10^6 cells/kg,intravenously infused via a central venous catheter)on day 1.day 15, day 29 and day 43 of the cycle. Cord blood will be given intravenously infused via a central venous catheter on day 2 of the cycle.


Outcome Measures
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Primary Outcome Measures :
  1. 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. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
  • Graft failure developing after auto-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
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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): NCT01763099


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, MD    +86-020-61641613    lansinglinren@hotmail.com   
Sponsors and Collaborators
Nanfang Hospital, Southern Medical University
Peking University People's Hospital
Sun Yat-sen University
Guangdong Provincial People's 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
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Principal Investigator: Qifa Liu, MD Nanfang Hospital, Southern Medical University
More Information
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Publications:

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Responsible Party: Nanfang Hospital, Southern Medical University
ClinicalTrials.gov Identifier: NCT01763099    
Other Study ID Numbers: NFH-MSC-auto-HSCT-2013
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013
Keywords provided by Nanfang Hospital, Southern Medical University:
Autologous Hematopoietic Stem Cell Transplantation
Mesenchymal Stem Cells
Cord Blood
Graft failure
Additional relevant MeSH terms:
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Hematologic Diseases