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Exploratory Clinical Study on Umbilical Cord Mesenchymal Stem Cells for Prophylaxis Against Endothelial Injury Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation

Exploratory Clinical Study on Umbilical Cord Mesenchymal Stem Cells for Prophylaxis Against Endothelial Injury Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122412
Enrollment
Unknown
Registered
2026-04-13
Start date
2026-04-13
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Endothelial Injury Syndrome

Interventions

Experimental group:Use human umbilical cord mesenchymal stem cell injection

Sponsors

Guabgzhou First People‘s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

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

MeasureTime 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

MeasureTime frame
Changes in serum markers of vascular endothelial injury;

Countries

China

Contacts

Public ContactShunqing Wang

Guabgzhou First People‘s Hospital

shqwang_cn@163.com+86 20 8104 8386

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026