Overview
Sponsor-declared trial summary
Patients with end-stage liver disease undergoing liver transplantation with deceased donor organ
Saftey evaluation of a tolerance induction protocol using immunomodulatory cell therapy following deceased donor liver transplantation
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-10-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Karolinska University Hospital Huddinge
External identifiers
- EU CT number
- 2024-514866-37-01
- EudraCT number
- 2020-001619-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy, Others
Saftey evaluation of a tolerance induction protocol using immunomodulatory cell therapy following deceased donor liver
transplantation
Secondary objectives 1
- To determine the percentage of patients that can achieve immunosuppression freedom at 36 months after liver transplantation.
Conditions and MedDRA coding
Patients with end-stage liver disease undergoing liver transplantation with deceased donor organ
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514866-37-00 | Cell-based immunotherapy in solid organ transplantation to minimize systemic immunosuppression | Karolinska University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Patients with indication for deceased donor liver transplantation.
- All genders
- Adult patients, 18 years or above
- MELD score <20
- Bar score <9
- WBC >2.0 x10^9 Cells/L
- Able to read and understand the meaning of the patient information and give written consent.
Exclusion criteria 7
- Recipients: Acute liver failure
- Recipients: Total trombosis of portal vein
- Recipients: Liver re-transplantation
- Recipients: Not fulfilling inclusion criteria's (shown above).
- Recipients: Female patients within child bearing age without proof of negative pregnancy test
- Recipients: Patient participating in other interventional study
- Donors: DCD donor or Partial liver-graft
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety evaluation of the protocol at 12 months after deceased donor liver transplantation.
Secondary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Donor specific immunomodulatory cells (DSIMC)
PRD11538436 · Product
- Active substance
- Dsimc
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Authorisation status
- Not Authorised
- MA holder
- KAROLINSKA
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Halsovagen, Flemingsberg Flemingsberg
- City
- Huddinge
- Postcode
- 141 86
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Bo-Göran Ericzon
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Bo-Göran Ericzon
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CISOT-protocol-v1-2-2023-03-16 final-signed-signed | 1 |
| Recruitment arrangements (for publication) | Blankt dokument 2024-514866-37-01-partII | 1 |
| Subject information and informed consent form (for publication) | patientinformation CISOT | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-23 | Sweden | Acceptable 2024-10-16
|
2024-10-17 |