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Trial record 89 of 535 for:    stem cell kidney

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 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 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 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 NCT01763099 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 Combined With Cord Blood for Treatment of Graft Failure
Official Title  ICMJE Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure Following Autologous Hematopoietic Stem Cell Transplantation
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hematopoietic Stem Cell Transplantation
  • Mesenchymal Stem Cells
  • Umbilical Cord Blood
  • Graft Failure
  • 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) 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Mesenchymal stem cells
    Mesenchymal stem cells group refers to treatment with mesenchymal stem cells (1×10^6 cells/kg, intravenously)
    Intervention: Biological: Mesenchymal stem cells
  • 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
    Intervention: Biological: Mesenchymal stem cells and cord blood
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
  • 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)
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 NCT01763099
Other Study ID Numbers  ICMJE NFH-MSC-auto-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 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  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