Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 11:14 PM
Study NCT ID:
NCT02063893
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Cancer Stem Cell Vaccinie to Treat Breast Cancer
Sponsor:
Fuda Cancer Hospital, Guangzhou
Organization:
Study Overview
Official Title:
Study of Cancer Stem Cell Vcccinie That as a Specific Antigen in Metastatic Adenocarcinoma of the Breast
Status:
COMPLETED
Status Verified Date:
2014-02
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:
CSC
Brief Summary:
Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinctmurine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity.
Detailed Description:
To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with Breast Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the Breast Cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the Breast Cancer patient using a similar protocol as investigators reported .
Aim 1: To demonstrate, in vitro, the relative cellular anti-Breast Cancer CSC immunity induced by Breast Cancer CSC-DC primed cytotoxic T cells.
Aim 2: To determine, in vitro, specific binding and lysis of Breast Cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with Breast Cancer CSC-DC.
Aim 1: To demonstrate, in vitro, the relative cellular anti-Breast Cancer CSC immunity induced by Breast Cancer CSC-DC primed cytotoxic T cells.
Aim 2: To determine, in vitro, specific binding and lysis of Breast Cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with Breast Cancer CSC-DC.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 201401 | OTHER_GRANT | The research fund of Fuda cancer hospital in Guangzhou | View |