Ignite Creation Date:
2024-05-05 @ 10:37 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01147380
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2010-06-17
Brief Title:
Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation
Sponsor:
Seigo Nishida
Organization:
University of Miami
Study Overview
Official Title:
A Novel Immunotherapy for Liver Transplant Patients With Hepatocellular Carcinoma Anti-tumor Effect of IL2-activated Donor Liver Natural Killer Cell
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIAMINK
Brief Summary:
The objective of this study is to evaluate feasibility and safety of the adoptive transfer of activated natural killer NK cells extracted from cadaveric donor liver graft perfusate for liver transplant recipients with hepatocellular carcinoma HCC
Detailed Description:
To investigate whether adoptive transfer of IL-2 stimulated NKcells extracted from cadaveric donor liver graft exudates into recipient with HCC will lead to prevent recurrence of HCC after liver transplantation
The method we plan to use is to collect NK cells from the cadaveric donor liver perfusate at the time of organ recovery The perfusate will be condensed by centrifuging and liver mononuclear cells LMNC were isolated by gradient centrifugation LMNC will be cultured with anti-CD3 antibody LMNC will be separted into a CD3-CD56 NK cell fraction and a non-NK cell fraction The purity of isolated fractions will be assessed by Flow cytometric analyses NK cells will be cultured with human recombinant IL-2 in 10 RPMI at 37 ºC in a 5 CO2 incubator NK cells will be infused intravenously to the recipient with HCC who have liver transplant from the same cadaveric donor at post operative day 4 in attempt to prevent the metastasis and recurrence of HCC
The method we plan to use is to collect NK cells from the cadaveric donor liver perfusate at the time of organ recovery The perfusate will be condensed by centrifuging and liver mononuclear cells LMNC were isolated by gradient centrifugation LMNC will be cultured with anti-CD3 antibody LMNC will be separted into a CD3-CD56 NK cell fraction and a non-NK cell fraction The purity of isolated fractions will be assessed by Flow cytometric analyses NK cells will be cultured with human recombinant IL-2 in 10 RPMI at 37 ºC in a 5 CO2 incubator NK cells will be infused intravenously to the recipient with HCC who have liver transplant from the same cadaveric donor at post operative day 4 in attempt to prevent the metastasis and recurrence of HCC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20100344 | OTHER | University of Miami IRB number | None |