Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629909
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis a Comprehensive Evaluation of Fibrosis Reduction Immunomodulation and Hepatic Regeneration a Single Center Randomized Phase I Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis a Comprehensive Evaluation of Fibrosis Reduction Immunomodulation and Hepatic Regeneration a Single Center Non-randomized Phase I Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell HUCMSC derived secretome injection is safe and effective in patient with liver cirrhosis The main questions it ams to answer are
1 How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients
2 How effective is secretome injection in liver fibrosis 6 months after injection
3 Does secretome injection improve liver function after 6 months after Injection
4 Does secretome injection affect Child Turcotte Pugh score
5 How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis
6 How does secretome injection affect the quality of life in live cirrhosis patient
7 What is the relationship between secretome injection and encephalopathy Researchers will compare secretome injection group patients who recieve secretome injections to best practice treatment group patient who receive supportive treatment including hepatoprotector and ursodeoxycolic acid
Researchers will compare the intervention group patients who are injected with HUCMSC derived secretome and control group patients who are only monitored and given their usual drugs
Patients will
Be injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months Do several test such us fibroscan stroop test psychometric hepatic encephalopathy score short form 36 questionnaire IL-6 TNF alfa and blood test for albumin SGOT SGPT direct bilirubin indirect bilirubin INR creatinine ureum hemoglobin hematocrite leukocyte and thrombocyte
Visit the clinic once every two weeks to receive drugs and treatment for 4 months
Follow up visit to review treatment progress on 3rd months 2 weeks post treatment 7th months 3 months post treatment10th months 6 months post treatment
1 How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients
2 How effective is secretome injection in liver fibrosis 6 months after injection
3 Does secretome injection improve liver function after 6 months after Injection
4 Does secretome injection affect Child Turcotte Pugh score
5 How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis
6 How does secretome injection affect the quality of life in live cirrhosis patient
7 What is the relationship between secretome injection and encephalopathy Researchers will compare secretome injection group patients who recieve secretome injections to best practice treatment group patient who receive supportive treatment including hepatoprotector and ursodeoxycolic acid
Researchers will compare the intervention group patients who are injected with HUCMSC derived secretome and control group patients who are only monitored and given their usual drugs
Patients will
Be injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months Do several test such us fibroscan stroop test psychometric hepatic encephalopathy score short form 36 questionnaire IL-6 TNF alfa and blood test for albumin SGOT SGPT direct bilirubin indirect bilirubin INR creatinine ureum hemoglobin hematocrite leukocyte and thrombocyte
Visit the clinic once every two weeks to receive drugs and treatment for 4 months
Follow up visit to review treatment progress on 3rd months 2 weeks post treatment 7th months 3 months post treatment10th months 6 months post treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None