Grant Award Details
Completion of preclinical stage development activities for an injectable pro-regenerative scaffold for treating symptomatic peripheral artery disease allowing for the conduct of a well-prepared pre-IND meeting with the FDA.
Grant Application Details
- Injectable pro-regenerative scaffold for treating symptomatic peripheral artery disease
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.
Major Proposed Activities
- Manufacture product to support nonclinical studies required by FDA
- Nonclinical safety studies
- Clinical trial planning and development
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.