Status:
COMPLETED
Study of Human Umbilical Cord-derived Mesenchymal Stem Cells for Treatment of Refractory Immune Thrombocytopenia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Thrombocytopenia
Mesenchymal Stem Cells
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 obser...
Detailed Description
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 thei...
Eligibility Criteria
Inclusion
- Aged 18 to 60 years old, male or female;
- Conform to the diagnostic criteria of immune Thrombocytopenia (ITP);
- Three months after splenectomy;
- The first-line treatment drugs such as human immunoglobulin, glucocorticoid, and the second-line treatment of thrombopoietin drugs and rituximab were invalid, or there was no response or recurrence after splenectomy;
- Diagnosis of ITP\>6 months；
- More than 3 months after rituximab treatment；
- Platelet counts \<30 ×10\^9/L, and bleeding tendency;
- People who are willing to sign the informed consent voluntarily and follow the research program.
- Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;
Exclusion
- ECOG score standard \>2；
- Secondary thrombocytopenic purpura;
- Patients with poor compliance;
- Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
- Pregnancy or lactation period;
- History of thrombosis;
- The serum chemistry results exceed the upper laboratory normal range by more than 20%, such as ALT, AST, TBIL, BUN, Cre etc;
- Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \[NYHA\] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \>450msec or QTc \> 480 for patients with a Bundle Branch Block;
- History of solid organ or bone marrow transplant;
- Researchers believe that patients should not participate in the test of any other condition.
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04014166
Start Date
November 21 2019
End Date
June 30 2023
Last Update
February 21 2025
Active Locations (1)
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1
Yunfei Chen
Tianjin, Tianjin Municipality, China, 300020