Aligned Nanofibrillar Scaffold Activated with HGF-mmRNA in Combination with Minced Muscle Graft for Treating Volumetric Muscle Loss (VML) Injury

Award Information
Agency: Department of Defense
Branch: Defense Health Program
Contract: W81XWH19C0021
Agency Tracking Number: H2-0402
Amount: $996,609.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: DHP14-009
Solicitation Number: 2014.1
Timeline
Solicitation Year: 2014
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-02-07
Award End Date (Contract End Date): 2021-07-06
Small Business Information
32930 Alvarado-Niles Rd., Union City, CA, 94587
DUNS: 023369802
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Michael Paukshto, PhD
 (650) 492-1440
 mpaukshto@fibralignbio.com
Business Contact
 Gregory King
Phone: (415) 902-4721
Email: gking@fibralignbio.com
Research Institution
N/A
Abstract
To address the scarcity of effective treatments for volumetric muscle loss injuries, we propose a novel aligned multilumen nanofibrillar collagen scaffold loaded with Hepatocyte Growth Factor (HGF) modified messenger RNA (mmRNA) to direct functional muscle regeneration. Due to both myogenic and angiogenic potency of HGF secreted by cells transfected in the scaffold, the scaffold will (1) attract and activate muscle satellite cells and direct the alignment of myoblasts within the defect site to facilitate seamless integration between healthy and regenerating tissue, and (2) recruit and activate vascular endothelial cells, and direct the formation of new capillaries along the myofibrils to guide vascularization of the new muscle tissue, for preventing or treating ischemia. This RNA-activated scaffold can be combined with an autologous minced muscle graft to provide the directional cues and integrate the composition into the mechanical transduction system surrounding the injury site to further enhance muscle regeneration. This combination is anticipated to provide superior results over the current standard of care involving minced grafts by helping to enhance the directional muscle repair and, importantly, with a substantial reduction in the volume of the autologous minced muscle graft, reducing the risk of morbidity of the donor site.

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