Ignite Creation Date:
2024-05-06 @ 12:50 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03860155
Status:
TERMINATED
Last Update Posted:
2021-11-17
First Post:
2019-01-31
Brief Title:
Allogeneic ABCB5-positive Stem Cells for Treatment of Acute-on-Chronic Liver Failure
Sponsor:
RHEACELL GmbH Co KG
Organization:
RHEACELL GmbH Co KG
Study Overview
Official Title:
An Interventional Single Arm Multicenter Phase IIIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-ACLF for the Treatment of Acute-on-Chronic Liver Failure ACLF
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Very slow recruitment of patients and the current COVID-19 pandemic situation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an interventional single arm multicenter phase IIIa clinical trial The study objective is to investigate the efficacy and safety of three iv doses of the investigational medicinal product IMP allo-APZ2-ACLF for the treatment of acute-on-chronic liver failure ACLF The allogeneic IMP allo-APZ2-ACLF contains skin-derived ABCB5-positive mesenchymal stem cells isolated from skin tissue of healthy donors and stored in a donor cell bank
Detailed Description:
This is an interventional phase IIIa 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 in patients with acute-on-chronic liver failure grade 2 and 3 The allogeneic IMP allo-APZ2-ACLF contains skin-derived ABCB5-positive mesenchymal stem cells isolated from skin tissue of healthy donors and stored in a donor cell bank
The clinical trial will be conducted in Germany and will consist of a screening treatment and efficacy follow-up period and a safety follow-up periodThe total duration is planned to be about 3 years including the follow-up period
The planned sample size is up to 18 treated patients 2 x 10e6 cellskg each at Day 0 Day 5 1 and Day 13 1 will be administrated into peripheral vein arm by use of a perfusor allo-APZ2-ACLF will be in a concentration of 1 x 10e7 cellsmL in HRG-solution In patients which require dialysis the IMP application has to be performed at least 3 hours after end of dialysis This is necessary to ensure that cells and secreted molecules are not cleared from the system by the dialysis
Patients will be followed up for 24 weeks with clinic visits at Weeks 3 4 8 12 16 20 and 24 after IMP application Further safety follow-ups will be scheduled as home interviews via telephone at Months 15 and 24 If necessary at the discretion of the investigator safety follow-ups at Months 15 and 24 can also be carried out as an on-site visit
The first six patients will be enrolled into the clinical trial consecutively with an interval of 2 weeks between the third IMP-application of the first patient and the enrolment of the second patient etc During this period the patient receives all three applications and immediate severe adverse effects allergic reactions SIRS that could occur after treatment would be reported before treatment start of the next patient
The safety data of these first six patients will be reviewed by the Medical Monitor continuously if required with assistance of the further members of the DSMB The safety evaluation of the DSMB will be submitted to the PEI and recruitment can only be continued after approval of an amendment
The clinical trial will be conducted in Germany and will consist of a screening treatment and efficacy follow-up period and a safety follow-up periodThe total duration is planned to be about 3 years including the follow-up period
The planned sample size is up to 18 treated patients 2 x 10e6 cellskg each at Day 0 Day 5 1 and Day 13 1 will be administrated into peripheral vein arm by use of a perfusor allo-APZ2-ACLF will be in a concentration of 1 x 10e7 cellsmL in HRG-solution In patients which require dialysis the IMP application has to be performed at least 3 hours after end of dialysis This is necessary to ensure that cells and secreted molecules are not cleared from the system by the dialysis
Patients will be followed up for 24 weeks with clinic visits at Weeks 3 4 8 12 16 20 and 24 after IMP application Further safety follow-ups will be scheduled as home interviews via telephone at Months 15 and 24 If necessary at the discretion of the investigator safety follow-ups at Months 15 and 24 can also be carried out as an on-site visit
The first six patients will be enrolled into the clinical trial consecutively with an interval of 2 weeks between the third IMP-application of the first patient and the enrolment of the second patient etc During this period the patient receives all three applications and immediate severe adverse effects allergic reactions SIRS that could occur after treatment would be reported before treatment start of the next patient
The safety data of these first six patients will be reviewed by the Medical Monitor continuously if required with assistance of the further members of the DSMB The safety evaluation of the DSMB will be submitted to the PEI and recruitment can only be continued after approval of an amendment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None