At a glance

ClinicalIndex Comparison Record

Phase 2Unknown· 60 target

Drug / intervention

Mesenchymal stem cells +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01763099

NCT01763099Phase 2Unknown

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Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure Following Autologous Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University·interventional·Posted Jan 8, 2013·Updated Jan 16, 2013

In Brief

A Phase 2 clinical trial evaluating Mesenchymal stem cells and Mesenchymal stem cells and cord blood for Hematopoietic Stem Cell Transplantation and 4 related conditions. Targeting 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHematopoietic Stem Cell Transplantation, Mesenchymal Stem Cells, Umbilical Cord Blood, Graft Failure, Hematological Diseases

CountriesChina

CollaboratorsPeking 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

Timeline

Phase 2UnknownOverdue

20132014201520162017201820192020202120222023202420252026

Enrollment StartJan 2013

First PostedJan 2013

Primary CompletionJan 2015

Study CompletionJan 2016

TodayJul 2026

First PostedJan 8, 2013

Enrollment StartJan 1, 2013

Primary CompletionJan 1, 2015

Study CompletionJan 1, 2016

TodayJul 1, 2026

Enrollment to primary: 2 yearsPosted 13.5 years ago

Interventions

Mesenchymal stem cellsbiological

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 and cord bloodbiological

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.