Status:
TERMINATED
Allogeneic ABCB5-positive Stem Cells for Treatment of Acute-on-Chronic Liver Failure
Lead Sponsor:
RHEACELL GmbH & Co. KG
Collaborating Sponsors:
FGK Clinical Research GmbH
Ticeba GmbH
Conditions:
Acute-On-Chronic Liver Failure
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an interventional, single arm, multicenter, phase I/IIa clinical trial. The study objective is to investigate the efficacy and safety of three i.v. doses of the investigational medicinal produ...
Detailed Description
This is an interventional, phase I/IIa clinical trial to investigate the efficacy (by changes in Model for End-Stage Liver Disease \[MELD\] score) and safety (by monitoring adverse events) of the IMP ...
Eligibility Criteria
Inclusion
- Male or female patients, aged 20 to 75 years;
- Diagnosed ACLF of grade 2 or 3 according to EASL-CLIF definition;
- Patients are not eligible for liver transplant (confirmed by transplantation board);
- Histology result of liver biopsy not older than 4 weeks before screening;
- Women of childbearing potential must have a negative blood pregnancy test at screening;
- Women of childbearing potential and fertile men, and their partners must be willing to use highly effective contraceptive methods during the course of the clinical trial;
- Written informed consent from patient, legal or authorized representative or a confirmation of justification of trial participation by an independent medical consultant. In case of confirmation by the independent medical consultant, a deferred informed consent from patient, legal or authorized representative has to be given.
Exclusion
- Patients without cirrhosis;
- Patients with ACLF grade 1 according to EASL-CLIF definition;
- Patient with septic shock;
- Patients with known hepatopulmonal syndrome (HPS);
- Patients with known pulmonary embolism that needs anticoagulative treatment;
- Patients with pre-existing lung disease with necessity of respiratory support;
- Active malignancy or history of malignancy within 5 years prior to trial entry;
- Known infection with human immunodeficiency virus (HIV˗1, HIV-2);
- Any known allergies to components of the IMP;
- Current or previous (within 30 days of enrolment) treatment with another IMP, or participation and/or under follow-up in another clinical trial;
- Patients anticipated to be unwilling or unable to comply with the requirements of the protocol;
- Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient's compliance, or place the patient at high risk of complications related to the treatment;
- Pregnant or nursing women;
- Employees of the sponsor, or employees or relatives of the investigator.
Key Trial Info
Start Date :
March 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03860155
Start Date
March 22 2019
End Date
March 26 2021
Last Update
November 17 2021
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum Carl-Gustav-Carus an der TU Dresden, Medizinische Klinik I
Dresden, Germany, 01307
2
Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie, Medizinisches Forschungszentrum
Essen, Germany, 45147
3
Universitätsklinikum Frankfurt, Medizinische Klinik 1, Sektion Translationale Hepatologie
Frankfurt, Germany, 60590
4
Universitätsklinikum Magdeburg A.ö.R., Medizinische Fakultät der Otto-von-Guericke-Universität
Magdeburg, Germany, 39120