Clinical trial • Gastroenterology
DSIMC for End-stage liver disease | Liver transplantation
Clinical trial of DSIMC for End-stage liver disease | Liver transplantation. 18 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- End-stage liver disease | Liver transplantation
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 23-09-2024
- First CTIS Authorization Date
- 17-10-2024
Trial design
Clinical trial across 1 site in Sweden.
- Target Sample Size
- 18
- Trial Duration For Participant
- 1095
Eligibility
Recruits 18 No vulnerable populations selected. Adults only (18 years or above). Written informed consent required: "Able to read and understand the meaning of the patient information and give written consent." No assent or paediatric consent provisions specified..
- Pregnancy Exclusion
- Recipients: Female patients within child bearing age without proof of negative pregnancy test
- Vulnerable Population
- No vulnerable populations selected. Adults only (18 years or above). Written informed consent required: "Able to read and understand the meaning of the patient information and give written consent." No assent or paediatric consent provisions specified.
Inclusion criteria
- {"criterion_text":"- Patients with indication for deceased donor liver transplantation.\n- All genders\n- Adult patients, 18 years or above\n- MELD score <20\n- Bar score <9\n- WBC >2.0 x10^9 Cells/L\n- Able to read and understand the meaning of the patient information and give written consent."}
Exclusion criteria
- {"criterion_text":"- Recipients: Acute liver failure\n- Recipients: Total trombosis of portal vein\n- Recipients: Liver re-transplantation\n- Recipients: Not fulfilling inclusion criteria's (shown above).\n- Recipients: Female patients within child bearing age without proof of negative pregnancy test\n- Recipients: Patient participating in other interventional study\n- Donors: DCD donor or Partial liver-graft"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Safety evaluation of the protocol at 12 months after deceased donor liver transplantation.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Percentage of patients that are completely weaned of immunosuppression at 36 months after liver transplantation with preserved optimal liver function, and level of immunosuppression used in patients not completely weaned from immunosuppression at the same time point","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 73
- Consent Approach
- Written informed consent obtained from participants. Participants must be able to read and understand the patient information and provide written consent. Adults only (18+). Subject information and informed consent form document is available. Languages not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 18
Sweden
- Earliest CTIS Part Ii Submission Date
- 09-10-2024
- Latest Decision Or Authorization Date
- 17-10-2024
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Transplantation Surgery
- Principal Investigator Name
- Bo-Göran Ericzon
- Principal Investigator Email
- bo-goran.ericzon@ki.se
- Contact Person Name
- Bo-Göran Ericzon
- Contact Person Email
- bo-goran.ericzon@ki.se
- Number Of Participants
- 18
Sponsor
Primary sponsor
- Full Name
- Karolinska University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Donor specific immunomodulatory cells (DSIMC)
- Active Substance
- DSIMC
- Modality
- Cell therapy
- Routes Of Administration
- INFUSION
- Route
- INFUSION
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