Injectable pro-regenerative scaffold for treating symptomatic peripheral artery disease
Grant Award Details
Grant Type:
Grant Number:
TRAN1-09814
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$2,839,317
Status:
Closed
Progress Reports
Reporting Period:
Final Operational Milestone #4
Grant Application Details
Application Title:
Injectable pro-regenerative scaffold for treating symptomatic peripheral artery disease
Public Abstract:
Translational Candidate
Injectable biomaterial derived from the natural scaffolding of porcine muscle
Area of Impact
Improving the quality of life of patients with symptomatic peripheral artery disease.
Mechanism of Action
The proposed mechanism of action is through recruitment of blood vessels and recruitment and differentiation of muscle stem cells. The injected material forms a new porous and fibrous scaffold, which contains appropriate tissue specific cues to stimulate muscle regeneration.
Unmet Medical Need
The prevalence of peripheral artery disease is high in adults and while there are currently some useful symptom improving therapies, there is an unmet need for new therapies for the numerous individuals where these approaches are not successful to improve blood flow and muscle function.
Project Objective
Pre-IND meeting
Major Proposed Activities
Injectable biomaterial derived from the natural scaffolding of porcine muscle
Area of Impact
Improving the quality of life of patients with symptomatic peripheral artery disease.
Mechanism of Action
The proposed mechanism of action is through recruitment of blood vessels and recruitment and differentiation of muscle stem cells. The injected material forms a new porous and fibrous scaffold, which contains appropriate tissue specific cues to stimulate muscle regeneration.
Unmet Medical Need
The prevalence of peripheral artery disease is high in adults and while there are currently some useful symptom improving therapies, there is an unmet need for new therapies for the numerous individuals where these approaches are not successful to improve blood flow and muscle function.
Project Objective
Pre-IND meeting
Major Proposed Activities
- Manufacture product to support nonclinical studies required by FDA
- Nonclinical safety studies
- Clinical trial planning and development
Statement of Benefit to California:
The prevalence of peripheral artery disease is 12% and represents a population that is approximately equal to that of coronary artery disease. The significant reduction in quality of life and high healthcare cost burden necessitates the development of new therapies for these patients. Our injectable biomaterial is a cost effective regenerative medicine strategy to improve blood flow and muscle function, thereby improving patient quality of life.
Publications
- Science (2019): Biomaterials for tissue repair. (PubMed: 30679357)
- Biomater Sci (2020): Dose optimization of decellularized skeletal muscle extracellular matrix hydrogels for improving perfusion and subsequent validation in an aged hindlimb ischemia model. (PubMed: 32432574)
- Methods (2020): Manufacturing considerations for producing and assessing decellularized extracellular matrix hydrogels. (PubMed: 31546012)