Invention novelty:
Stem cells are harnessed to create a stent-based “paracrine factor factory” using a novel biodegradable nanofiber sleeve which protects the cells from washout and immune attack, and provides a sheltered in vivo on-stent milieu for the cells to continuously produce and deliver healing growth factors and exosomes to injured tissue.
Value Proposition:
Current methods to administer stem cells to the heart, including intracoronary infusion or direct intramyocardial injection, do not allow for prolonged retention of the cells, and therefore do not lead to a sustained growth factor release. Rapid cell washout, diffusion, immune attack, and an inhospitable environment are some factors that limit cardiac retention of viable stem cells and, consequently, the opportunity for the stem cells to produce sufficient growth factors to result in robust clinical effects.
The novel cell-impregnated nanofiber sleeve technology employs a biodegradable nanofiber fabric to cage stem cells onto stents and other medical devices. The nanofiber sleeve acts as a substrate on which the stem cells grow, and as a protective semi-permeable barrier that prevents washout of the stem cells into the bloodstream, excludes host immune cells, and at the same time, allows free passage of growth factors, exosomes, nutrients and wastes as well as the host's signaling cytokines. With the stem cells protected, the nanofiber sleeve behaves as an intravascular factory that produces and releases therapeutic growth factors and exosomes directly into the circulation and to the injured tissue.
Advantages of the technology includes:
• Cell-based intravascular production of pro-healing growth factors and exosomes in vivo, directly on-stent and in damaged tissue
• Isolation of cells from the immune system, allowing the use of “off-the-shelf” allogeneic cells from healthy donors.
• Protection of cells from wash-out, allowing prolonged production of therapeutic factors.
• Nanofiber sleeves can be tailored to biodegrade over different time scales required for healing.
• Can be used to cover other medical devices such as pacemakers, ICDs, and leads, or applied directly in the tissue
Technical Details:
Johns Hopkins researchers have developed a method by which stem cell delivery to the heart can be achieved successfully through a novel stents sleeve. Using this method, the nanofiber stent sleeve can be wrapped around a stent to provide a platform by which abundant numbers of stem cells can be placed directly at a site proximal to the injured tissue, shielded from washout and immune attack, so that ample and continuous localized production of pro-healing growth factors directly to the damaged tissue can take place.
Looking for Partners: To develop and commercialize the technology as a “Cell Impregnated Nanofiber Stent Sleeve” (CINSS)
Stage of Development: Pre-Clinical
Data Availability: Under CDA/NDA
Inventors: Chao-Wei Hwang, Zhiyong Xia, Peter Johnston, Gary Gerstenblith, Gordon Tomaselli, Robert Weiss, Virginia Bogdan, Jeffrey Brinker, Steven Schulman
