Thrombocytopenia Clinical Trial
Official title:
Study of Human Umbilical Cord-derived Mesenchymal Stem Cells for Treatment of Refractory Immune Thrombocytopenia
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.
Human umbilical cord (hUC)-derived mesenchymal stem cells (MSCs) have been shown to have marked therapeutic effects in a number of inflammatory diseases and autoimmune diseases in humans based on their potential for immunosuppression and their low immunogenicity. Currently, no more data is available on the safety and effectiveness of hUC-MSCs to treat immune thrombocytopenia patients. This is a single-arm study to evaluate the safety and efficacy of hUC-MSCs to treat refractory immune thrombocytopenia（ITP）. In addition, it is the objective of this study to observe the changes of immune function in refractory ITP patients after hUC-MSCs infusion, and to explore and reveal the mechanism of hUC-MSCs in treating ITP. The investigator will assess the changes of the platelet counts after hUC-MSCs infusion from week 1 to week 28, and observe incidence of adverse events during and after hUC-MSCs infusion.The investigator will complete virus detection( including HBV, HCV, HIV, Syphilis, etc) at week 4 and week 16 after hUC-MSCs infusion. 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. The investigator will observe the concentration of hUC-MSCs in peripheral blood from female patients after the first hUC-MSCs infusion at 10 time points, including 30 minutes before hUC-MSCs infusion, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 16 hours, 24 hours,48 hours and 96 hours after the first hUC-MSCs infusion. The investigator will detect antibody production of hUC-MSCs in peripheral blood from the first 9 patients at 2 time points, including 30 minutes before the first hUC-MSCs infusion and 48 hours after the last hUC-MSCs infusion. The investigator will observe the changes of immune function in refractory ITP patients after hUC-MSCs infusion at 7 time points, including one day before hUC-MSCs infusion, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16weeks and 28 weeks after hUC-MSCs infusion. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04003220 -
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
|
||
| Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Recruiting |
NCT03633019 -
High-dose Use of rhTPO in CIT Patients
|
Phase 4 | |
| Recruiting |
NCT06087198 -
Clinical Performance Evaluation of T-TAS®01 HD Chip
|
||
| Recruiting |
NCT03605511 -
TTP and aHUS in Complicated Pregnancies
|
||
| Active, not recruiting |
NCT03688191 -
Study of Sirolimus in CTD-TP in China
|
Phase 4 | |
| Completed |
NCT02845609 -
Efficacy of Sialic Acid GNE Related Thrombocytopenia
|
Phase 2 | |
| Recruiting |
NCT02241031 -
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia
|
Phase 2/Phase 3 | |
| Recruiting |
NCT02244658 -
Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia
|
Phase 3 | |
| Completed |
NCT01356576 -
Effect of Hemodialysis Membranes on Platelet Count
|
N/A | |
| Unknown status |
NCT01196884 -
Immune Thrombocytopenia (ITP) Immune-Genetic Assessment
|
||
| Terminated |
NCT01368211 -
Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study)
|
Phase 2/Phase 3 | |
| Completed |
NCT00039858 -
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
|
Phase 4 | |
| Completed |
NCT00787241 -
Platelet Count Trends in Pre-eclamptic Parturients
|
N/A | |
| Completed |
NCT00001533 -
Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine
|
Phase 1 | |
| Not yet recruiting |
NCT06036966 -
The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
|
Phase 2 | |
| Completed |
NCT01791101 -
Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.
|
Phase 2 | |
| Recruiting |
NCT06053021 -
Antiplatelet Therapy for AIS Patients With Thrombocytopenia
|
N/A | |
| Recruiting |
NCT03701217 -
Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05958511 -
Assessment of Risk Factors and Outcome of Thrombocytopenia in ICU Patients
|