RECRUITING

Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes

Conditions

End Stage Liver Disease Allogeneic Organogenesis Hepatocyte Transplantation Liver Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2a, Open Label, Dose Escalation Study for Safety, Tolerability, and Efficacy of Hepatocyte Transplantation Into Periduodenal Lymph Nodes Among Subjects With End-Stage Liver Disease

Quick Facts

Study Start:2022-03-11

Study Completion:2026-08-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04496479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Have read, understood, and signed the informed consent form (ICF). 2. Adults of either gender and ages 18 to 70 years old with a diagnosis of ESLD due to alcohol, chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections, autoimmune hepatitis, primary sclerosis cholangitis, primary biliary cirrhosis (cholangitis), cirrhosis as the result of Wilson disease, hemochromatosis, sarcoidosis and alpha 1 antitrypsin deficiency, cryptogenic cirrhosis, and nonalcoholic steatohepatitis cirrhosis with a MELD-Na score \>10 and \<25 at screening. 3. Subjects must have a body mass index (BMI) \<35. 4. Subjects with HCV associated ESLD must have been treated and demonstrate 24 weeks of negative HCV ribonucleic acid (RNA). 5. Subjects with HBV must be on stable therapy for 6 months and have HBV deoxyribonucleic acid \<500 c/mL. 6. Women of childbearing potential (WOCBP) or sexual partners of male subjects who are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 1 month after the last study visit. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; HMA, 2014). For the definition and list of highly effective methods of contraception, see Appendix 1. 7. Has stable control of portal hypertension and upper gastrointestinal bleeding with medical therapy and/or endoscopic therapy. 8. If the subject has undergone a TIPS procedure for the clinical management of portal hypertension, they must be stable after the successful TIPS procedure, and not experiencing serious complications from the TIPS procedure itself (e.g., infection and intractable hepatic encephalopathy). 9. Has blood urea nitrogen (BUN) \<80 mg/dL. 10. Has an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2. 11. Agrees to avoid alcohol consumption during the study. 12. Is willing and able to comply with all requirements of the study protocol.	1. Has primary hepatic neoplasms (hepatocellular carcinoma and cholangiocarcinoma). 2. Has active and/or uncontrolled severe infections requiring hospitalization and prolonged antimicrobial therapy. 3. Has severe coagulopathy (international normalized ratio \[INR\] \>2, and/or platelet count \<50,000/μL). 4. Has psychiatric and/or social issues that could lead to noncompliance. 5. Has an extrahepatic neoplastic disease requiring active chemotherapy, immunotherapy, and/or surgical resection. 6. Has previously treated neoplastic disease with less than a 2-year cancer free period. 7. Pregnant and lactating women should not be in the study. 8. Known hypersensitivity to human serum albumin. 9. Subjects with uncontrolled hypertension (defined as a diastolic blood pressure of 110 mmHg or higher). 10. Has recurrent/intractable ascites refractory to diuretics and requiring periodic large volume paracentesis. 11. Has primary alcoholic liver disease and has not demonstrated abstinence for at least 24 weeks (6 months) prior to enrollment while attending mandatory rehab programs (e.g., Alcoholics Anonymous) and psychotherapy. 12. Has grade 3 esophageal varices requiring the continuous use of propranolol and cannot afford to have this medication withheld and/or discontinued. 13. Has a Child-Turcotte-Pugh (CTP) Class of C. 14. Is receiving or plans to receive treatment with another investigational product or device.

Inclusion Criteria

Exclusion Criteria

1. Have read, understood, and signed the informed consent form (ICF).
2. Adults of either gender and ages 18 to 70 years old with a diagnosis of ESLD due to alcohol, chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections, autoimmune hepatitis, primary sclerosis cholangitis, primary biliary cirrhosis (cholangitis), cirrhosis as the result of Wilson disease, hemochromatosis, sarcoidosis and alpha 1 antitrypsin deficiency, cryptogenic cirrhosis, and nonalcoholic steatohepatitis cirrhosis with a MELD-Na score \>10 and \<25 at screening.
3. Subjects must have a body mass index (BMI) \<35.
4. Subjects with HCV associated ESLD must have been treated and demonstrate 24 weeks of negative HCV ribonucleic acid (RNA).
5. Subjects with HBV must be on stable therapy for 6 months and have HBV deoxyribonucleic acid \<500 c/mL.
6. Women of childbearing potential (WOCBP) or sexual partners of male subjects who are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 1 month after the last study visit. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; HMA, 2014). For the definition and list of highly effective methods of contraception, see Appendix 1.
7. Has stable control of portal hypertension and upper gastrointestinal bleeding with medical therapy and/or endoscopic therapy.
8. If the subject has undergone a TIPS procedure for the clinical management of portal hypertension, they must be stable after the successful TIPS procedure, and not experiencing serious complications from the TIPS procedure itself (e.g., infection and intractable hepatic encephalopathy).
9. Has blood urea nitrogen (BUN) \<80 mg/dL.
10. Has an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2.
11. Agrees to avoid alcohol consumption during the study.
12. Is willing and able to comply with all requirements of the study protocol.

1. Has primary hepatic neoplasms (hepatocellular carcinoma and cholangiocarcinoma).
2. Has active and/or uncontrolled severe infections requiring hospitalization and prolonged antimicrobial therapy.
3. Has severe coagulopathy (international normalized ratio \[INR\] \>2, and/or platelet count \<50,000/μL).
4. Has psychiatric and/or social issues that could lead to noncompliance.
5. Has an extrahepatic neoplastic disease requiring active chemotherapy, immunotherapy, and/or surgical resection.
6. Has previously treated neoplastic disease with less than a 2-year cancer free period.
7. Pregnant and lactating women should not be in the study.
8. Known hypersensitivity to human serum albumin.
9. Subjects with uncontrolled hypertension (defined as a diastolic blood pressure of 110 mmHg or higher).
10. Has recurrent/intractable ascites refractory to diuretics and requiring periodic large volume paracentesis.
11. Has primary alcoholic liver disease and has not demonstrated abstinence for at least 24 weeks (6 months) prior to enrollment while attending mandatory rehab programs (e.g., Alcoholics Anonymous) and psychotherapy.
12. Has grade 3 esophageal varices requiring the continuous use of propranolol and cannot afford to have this medication withheld and/or discontinued.
13. Has a Child-Turcotte-Pugh (CTP) Class of C.
14. Is receiving or plans to receive treatment with another investigational product or device.

Contacts and Locations

Study Contact

Paulo Fontes, MD

CONTACT

412-860-3599

fontesp@lygenesis.com

Principal Investigator

Paulo Fontes, MD

STUDY_CHAIR

LyGenesis, Inc.

Study Locations (Sites)

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: LyGenesis, Inc.

Paulo Fontes, MD, STUDY_CHAIR, LyGenesis, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-11

Study Completion Date2026-08-07

Study Record Updates

Study Start Date2022-03-11

Study Completion Date2026-08-07

Terms related to this study

Keywords Provided by Researchers

Allogeneic
Organogenesis
Hepatocyte
Transplantation
Liver Disease

Additional Relevant MeSH Terms

End Stage Liver Disease