Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
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ClinicalTrials.gov Identifier: NCT04496479 |
Recruitment Status :
Recruiting
First Posted : August 3, 2020
Last Update Posted : September 21, 2023
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Sponsor:
LyGenesis, Inc.
Information provided by (Responsible Party):
LyGenesis, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | July 22, 2020 | ||||
First Posted Date ICMJE | August 3, 2020 | ||||
Last Update Posted Date | September 21, 2023 | ||||
Actual Study Start Date ICMJE | March 11, 2022 | ||||
Estimated Primary Completion Date | February 22, 2026 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
Effectiveness of Selected Treatment to Modify the Liver Function Panel [ Time Frame: Week 52 ] Evaluate the effectiveness of hepatocyte transplants in modifying the liver function panel (total serum bilirubin, ammonia, prothrombin time, international normalized ratio, sodium, blood urea nitrogen, and creatinine) as measured through changes in laboratory biomarkers caused by end-stage liver disease
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Original Secondary Outcome Measures ICMJE |
Effectiveness of Selected Treatment to Modify the Liver Function Panel Compared to Placebo [ Time Frame: Week 24 ] Evaluate the effectiveness of hepatocyte transplants in modifying the liver function panel (total serum bilirubin, ammonia, prothrombin time, international normalized ratio, sodium, blood urea nitrogen, and creatinine) as measured through changes in laboratory biomarkers caused by progressive and irreversible end-stage liver disease as compared to placebo
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. | ||||
Detailed Description | This safety, tolerability, and efficacy study includes an open-label dose-escalation phase for up to 12 subjects with end-stage liver disease (ESLD). | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: Open-Label Dose Escalation of Three Increasing Dosages Masking: None (Open Label)Masking Description: This is no masking in the open-label dose escalation phase. Primary Purpose: Treatment
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Condition ICMJE | End Stage Liver Disease | ||||
Intervention ICMJE | Biological: LYG-LIV0001
Allogenic hepatocytes suspended in a buffered cell preservation solution with increasing number of lymph nodes being transplanted for the dose escalation. Subjects will also receive immune suppression, including tacrolimus capsules to follow the dose prescribed by the investigator as well as a short course of prednisone.
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Study Arms ICMJE | Experimental: LYG-LIV0001
Open label group of subjects with end stage liver disease receiving increasing doses of the experimental therapy.
Intervention: Biological: LYG-LIV0001
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
12 | ||||
Original Estimated Enrollment ICMJE |
45 | ||||
Estimated Study Completion Date ICMJE | August 7, 2026 | ||||
Estimated Primary Completion Date | February 22, 2026 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04496479 | ||||
Other Study ID Numbers ICMJE | LYG-LIV-02-01 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | LyGenesis, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | LyGenesis, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | LyGenesis, Inc. | ||||
Verification Date | September 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |