CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)other
Likely dose
Not stated in record
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NCT04014166N/ACompleted
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Study of Human Umbilical Cord-derived Mesenchymal Stem Cells for Treatment of Refractory Immune Thrombocytopenia

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Jul 10, 2019·Updated Feb 21, 2025

In Brief

A clinical study evaluating Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) for Thrombocytopenia and Mesenchymal Stem Cells. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Primary Objective: To evaluate the safety and efficacy of human umbilical cord-derived mesenchymal stem cells（hUC-MSCs） to treat refractory immune thrombocytopenia（ITP）. Secondary Objective: To observe the changes of immune function in refractory ITP patients with human umbilical cord-derived mesenchymal stem cells（hUC-MSCs） after infusion, and to explore and reveal the mechanism of hUC-MSCs in treating ITP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopenia, Mesenchymal Stem Cells
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 10, 2019
Enrollment StartNov 21, 2019
Primary CompletionFeb 28, 2023
Study CompletionJun 30, 2023
TodayJul 1, 2026
Enrollment to primary: 3.3 yearsPosted 7.0 years ago

Interventions

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

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.