Actively Recruiting
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
Led by LyGenesis, Inc. · Updated on 2025-08-08
12
Participants Needed
2
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
CONDITIONS
Official Title
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years with end-stage liver disease due to alcohol, HBV, HCV, autoimmune hepatitis, primary sclerosis cholangitis, primary biliary cirrhosis, Wilson disease, hemochromatosis, sarcoidosis, alpha 1 antitrypsin deficiency, cryptogenic cirrhosis, or nonalcoholic steatohepatitis cirrhosis
- MELD-Na score greater than 10 and less than 25 at screening
- Body mass index (BMI) less than 35
- For HCV-related ESLD, treated and 24 weeks of negative HCV RNA
- For HBV, stable therapy for 6 months and HBV DNA less than 500 c/mL
- Women of childbearing potential or their partners must use at least one highly effective contraception method during the study and for 1 month after
- Stable control of portal hypertension and upper gastrointestinal bleeding with medical and/or endoscopic therapy
- If undergone TIPS procedure, must be stable without serious complications
- Blood urea nitrogen (BUN) less than 80 mg/dL
- Estimated glomerular filtration rate (eGFR) 45 mL/min/1.73 m2 or higher
- Agrees to avoid alcohol during the study
- Willing and able to comply with all study requirements
You will not qualify if you...
- Primary hepatic neoplasms such as hepatocellular carcinoma or cholangiocarcinoma
- Active or uncontrolled severe infections requiring hospitalization and prolonged antimicrobial therapy
- Severe coagulopathy with INR greater than 2 or platelet count less than 50,000/µL
- Psychiatric or social issues that may lead to noncompliance
- Extrahepatic neoplastic disease requiring active chemotherapy, immunotherapy, or surgery
- Previously treated neoplastic disease with less than 2 years cancer-free period
- Pregnant or lactating women
- Known allergy to human serum albumin
- Uncontrolled hypertension (diastolic blood pressure 110 mmHg or higher)
- Recurrent or intractable ascites not responding to diuretics and needing frequent large volume paracentesis
- Primary alcoholic liver disease without demonstrated abstinence for at least 24 weeks prior to enrollment
- Grade 3 esophageal varices requiring continuous propranolol that cannot be stopped
- Child-Turcotte-Pugh Class C
- Receiving or planning treatment with another investigational product or device
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Withdrawn
2
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Paulo Fontes, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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