Study of Human Umbilical Cord-derived Mesenchymal Stem Cells for Treatment of Refractory Immune Thrombocytopenia

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 21, 2019

Primary Completion Date

February 28, 2023

Study Completion Date

June 30, 2023

Conditions
ThrombocytopeniaMesenchymal Stem Cells
Interventions
OTHER

Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)

This is a single-arm study to evaluate the safety and efficacy of hUC-MSCs to treat refractory immune thrombocytopenia. The dose of hUC-MSCs will be successively divided into three increasing dose(group A: hUC-MSCs 0.5×10\^6/kg, weekly for 4 weeks, 3 patients; group B: hUC-MSCs 1.0×10\^6/kg, weekly for 4 weeks, 3 patients; hUC-MSCs 2.0×10\^6/kg, weekly for 4 weeks, 3 patients) with 3 patients in each group according to the dose. The principle of increasing dose will be carried out successively from low dose to high dose group. According to the results of the safety and efficacy data from these 9 patients, the investigator will determine one of the doses and expand the sample size to 6 cases.

Trial Locations (1)

300020

Yunfei Chen, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER

NCT04014166 - Study of Human Umbilical Cord-derived Mesenchymal Stem Cells for Treatment of Refractory Immune Thrombocytopenia | Biotech Hunter | Biotech Hunter