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

NCT01763099 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-01-16

No results posted yet for this study

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.

Conditions

  • Hematopoietic Stem Cell Transplantation
  • Mesenchymal Stem Cells
  • Umbilical Cord Blood
  • Graft Failure
  • Hematological Diseases

Interventions

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Guangzhou General Hospital of Guangzhou Military Command

    collaborator OTHER

  • Southern Medical University, China

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Guangzhou First People's Hospital

    collaborator OTHER

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-01-31
Completion
2016-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01763099 on ClinicalTrials.gov