Neurogenic hydrogel stimulation of stem cells to regenerate radiation-damaged salivary glands
Grant Award Details
Grant Type:
Grant Number:
TRAN1-15330
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$2,312,021
Status:
Active
Grant Application Details
Application Title:
Neurogenic hydrogel stimulation of stem cells to regenerate radiation-damaged salivary glands
Public Abstract:
Translational Candidate
Ceviginate is a neuromimetic encapsulated in a hydrogel
Area of Impact
Dry mouth as a result of injury to the salivary glands by radiation therapy for head and neck cancer
Mechanism of Action
Regenerate damaged salivary gland tissue through neurogenic stimulation of stem cells
Unmet Medical Need
Current treatment options for dry mouth/xerostomia, such as oral pills and rinses, merely alleviate symptoms but fail to address the underlying cause of dry mouth. With no regenerative treatments available, this medical condition is irreversible.
Project Objective
pre-IND meeting
Major Proposed Activities
Ceviginate is a neuromimetic encapsulated in a hydrogel
Area of Impact
Dry mouth as a result of injury to the salivary glands by radiation therapy for head and neck cancer
Mechanism of Action
Regenerate damaged salivary gland tissue through neurogenic stimulation of stem cells
Unmet Medical Need
Current treatment options for dry mouth/xerostomia, such as oral pills and rinses, merely alleviate symptoms but fail to address the underlying cause of dry mouth. With no regenerative treatments available, this medical condition is irreversible.
Project Objective
pre-IND meeting
Major Proposed Activities
- Safety and dosing study in a large animal model
- Production of R&D grade Ceviginate, development and validation of quality controls/analytical protocols, and packaging stability testing, aging
- Develop First in Human (FIH) Clinical Trial Design
Statement of Benefit to California:
Our mission is to overcome xerostomia or dry mouth through restoring salivary gland function. With no regenerative treatments available, xerostomia is irreversible. Based on this unmet need, we are developing a long-term therapeutic treatment to restore salivary flow through activating salivary gland regeneration. This will be the first regenerative treatment for this medical condition and gives cancer survivors and their families the chance to restore their quality of life.