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

NCT01763086 · 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 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.

Conditions

  • Stem Cell Transplantation, Hematopoietic
  • Mesenchymal Stem Cells
  • Poor Graft Function
  • 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. 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.

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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

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 NCT01763086 on ClinicalTrials.gov