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A small sample clinical study of the safety and initial efficacy of exosomes in the treatment of cirrhosis

A small sample clinical study of the safety and initial efficacy of exosomes in the treatment of cirrhosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075676
Enrollment
Unknown
Registered
2023-09-12
Start date
2023-08-29
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Liver Cirrhosis

Interventions

Exosome Treatment Group:Menstrual Blood Mesenchymal Stem Cell derived exosomes

Sponsors

Shulan (Hangzhou)Hospital Affiliated to Zhejiang Shuren University Shulan International Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18-75 years old (including boundary value); (2) Meet the diagnostic criteria for liver cirrhosis in the Guidelines for Diagnosis and Treatment of Liver Cirrhosis (2019 edition); (3) Hepatic cirrhosis portal vein pressure was measured by HVPG=10mmHg; (4) The subjects' heart, lungs, kidneys and other important organs function normally; (5) Child-Pugh score is grade A to B (5-9 points) and MELD score =20 points; (6) Prothrombin activity greater than 40% (prothrombin time less than 18 seconds), platelets greater than 30×10^9 /L; (7) The subject (or guardian) has signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) People who are highly allergic or have a history of severe allergy or allergy to known ingredients of the drug or have a history of iodine allergy; (2) The Child-Pugh score of cirrhosis was grade C (10-15 points), the MELD score was > 20 points, and the total bilirubin was > 3mg/dL; (3) Gastrointestinal hemorrhage, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute infection; (4) Patients treated with portal vein thrombosis and TIPS (5) Malignant tumors of the liver or other organs; (6) dysfunction of the heart, lungs, kidneys and other important organs of the whole body; (7) with AIDS, syphilis, tuberculosis and other infectious diseases; (8) The patient was enrolled in another trial study 10 days before the trial or will be enrolled in another trial study within 90 days after the trial begins; (9) Pregnant and lactating women and men who have a birth plan within one year; (10) Combined with severe bacterial infection; (11) Have participated in stem cell clinical research; (12) is receiving other arterial dosing or therapy that may affect the dosing operator in this trial; (13) drug addiction or alcohol abuse; (14) splenectomy patients; (15) Other researchers did not consider the subjects suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Hepatic Venous Pressure Gradient(HVPG);Liver biopsy;Adverse events/serious adverse events rate;Laboratory examination;Vital sign;Physical examination;electrocardiogram;

Secondary

MeasureTime frame
Liver function;Complication rate;MELD Score?Child Score?FIB-4 Score and SF-36 Score;Liver Stiffness Measure, CAP, Spleen Stiffness;Imaging index;

Countries

China

Contacts

Public ContactHuadong Yan

Shulan (Hangzhou)Hospital Affiliated to Zhejiang Shuren University Shulan International

huadongy588@163.com+86 135 8657 9885

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026