Vascular Endothelial Injury Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 years or older and 60 years or younger, gender not restricted; 2. Patients who were scheduled to undergo allogeneic hematopoietic stem cell transplantation due to various reasons before being included in this study; 3. Have the conditions for undergoing allogeneic hematopoietic stem cell transplantation; 4. Are willing and able to comply with the research procedures and conditions; 5. Will undergo at least 6 months of treatment and follow-up; 6. Voluntarily participate in this clinical trial and sign the informed consent form, and can complete all follow-up contents as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Positive for Human Immunodeficiency Virus type 1 or 2 (HIV-1 and HIV-2), hepatitis B, hepatitis C or Human T-lymphotropic virus-1 (HTLV-1), with VSV-G antibody; 2. Active bacterial, viral, fungal or parasitic infections; 3. History of other chronic diseases unrelated to transplantation treatment; 4. Previously received autologous or allogeneic hematopoietic stem cell transplantation; 5. Siblings have known or suspected familial cancer syndromes (including but not limited to breast cancer, rectal cancer, ovarian cancer, prostate cancer and pancreatic cancer); 6. Diagnosed with major mental illness that will seriously affect the ability to participate in clinical research; 7. Active malaria; 8. History of major organ damage, including: liver diseases, transaminase levels exceeding the normal upper limit by more than 3 times; histopathological evidence of bridging fibrosis cirrhosis or acute hepatitis in liver biopsy; heart diseases, heart disease with left ventricular ejection fraction lower than 25% of normal; kidney diseases with calculated creatinine clearance rate less than 30% of normal value; doctors consider high-risk VTE to be too severe; clinical evidence of obvious need for medical intervention for pulmonary hypertension; 9. Any other situation that the doctor considers as making the subject unsuitable for enrollment; 10. Participated in another investigational drug clinical study within 30 days of screening; 11. Subjects with fertility intention within the 6-month study period; 12. Subjects or their parents have poor compliance with the study protocol; 13. Received vascular interventional therapy within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Stratification of vascular endothelial cell injury syndrome severity after UC-MSCs cell reinfusion;All laboratory parameters, the number and severity of clinical adverse events were recorded;Flow cytometry changes in peripheral blood endothelial cells;Adverse reactions of UC-MSCs cell products during reinfusion;Adverse reactions within 180 days after reinfusion of UC-MSCs cell products;Incidence of vascular endothelial cell injury syndrome after UC-MSCs cell reinfusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in serum markers of vascular endothelial injury; | — |
Countries
China
Contacts
Guabgzhou First People‘s Hospital