Actively Recruiting
Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
Led by Beijing 302 Hospital · Updated on 2024-10-18
140
Participants Needed
7
Research Sites
155 weeks
Total Duration
On this page
Sponsors
B
Beijing 302 Hospital
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions. This clinical trial is to inspect the efficiency and safety of mesenchymal stem cells (MSCs) therapy for decompensated cirrhosis.
CONDITIONS
Official Title
Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide written informed consent
- Aged 18 to 75 years, male or female
- Diagnosed with decompensated liver cirrhosis based on clinical, laboratory, imaging, or pathological findings
- MELD score between 15 and 30 points
You will not qualify if you...
- Active variceal bleeding, overt hepatic encephalopathy, refractory ascites, or hepatorenal syndrome within 1 month prior to screening
- Uncontrolled severe infection within 2 weeks of screening
- Hepatitis B patients with less than 12 months antiviral therapy, discontinuation during study, or detectable HBV DNA at screening
- Hepatitis C patients with less than 12 months antiviral therapy, discontinuation during study, or detectable HCV RNA at screening (except undetectable HCV RNA without treatment)
- Corticosteroid treatment for autoimmune hepatitis less than 6 months
- Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to inclusion
- Active alcohol drinkers unwilling to stop after inclusion
- Significant renal insufficiency or severe electrolyte abnormalities
- Biliary obstruction or portal vein spongiosis
- History of splenic cut-off flow surgery
- Malignant tumors within 5 years except certain skin cancers after curative treatment
- Prior major organ transplantation or significant diseases of heart, lung, kidney, blood, endocrine systems
- Drug abuse, dependence, methadone treatment, or psychosis
- Positive HIV or syphilis antibody tests
- Pregnancy, lactation, or recent fertility plans during and 6 months after study
- Severe allergies or allergy to investigational drug or excipients
- History of pulmonary embolism
- Previous stem cell therapy or intolerance to cell therapy
- Planned liver transplant within 3 months
- Participation in other clinical trials within last 3 months
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Not Yet Recruiting
2
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Hainan hospital of Chinese PLA General Hospital
Sanya, Hainan, China
Actively Recruiting
4
Jin Yin-tan Hospital
Wuhan, Hubei, China
Not Yet Recruiting
5
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
6
Xinjiang Kashi Area Number 1 Hospital
Kashgar, Xinjiang, China
Not Yet Recruiting
7
Beijing 302 Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lei Shi, MD,PhD
CONTACT
F
Fu-Sheng Wang, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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