Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 5, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 16, 2013
January 1, 2013
2 years
January 5, 2013
January 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hematopoietic recovery
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.
1 year
Secondary Outcomes (1)
infections, primary underlying disease relapse and any toxic side effects of MSCs treatment
1 year
Study Arms (2)
Mesenchymal stem cells
EXPERIMENTALMesenchymal stem cells group refers to treatment with mesenchymal stem cells (1×10\^6 cells/kg, intravenously)
Mesenchymal stem cells and cord blood
EXPERIMENTALMesenchymal 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Peking University People's Hospitalcollaborator
- Sun Yat-sen Universitycollaborator
- Guangdong Provincial People's Hospitalcollaborator
- Guangzhou General Hospital of Guangzhou Military Commandcollaborator
- Southern Medical University, Chinacollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Guangzhou First People's Hospitalcollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (2)
Koc ON, Lazarus HM. Mesenchymal stem cells: heading into the clinic. Bone Marrow Transplant. 2001 Feb;27(3):235-9. doi: 10.1038/sj.bmt.1702791.
PMID: 11277170BACKGROUNDSmith AR, Wagner JE. Alternative haematopoietic stem cell sources for transplantation: place of umbilical cord blood. Br J Haematol. 2009 Oct;147(2):246-61. doi: 10.1111/j.1365-2141.2009.07828.x.
PMID: 19796274BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu, MD
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2013
First Posted
January 8, 2013
Study Start
January 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2016
Last Updated
January 16, 2013
Record last verified: 2013-01