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CMCC 2364

A cell-free, silk-based scaffold for regenerating bladder tissue

Inventors: Joshua Mauney, Carlos Estrada

Invention Types: Other, Medical Device

Research Areas: Regenerative Medicine, Urology

Keywords: Instrumentation, Method of Use, Surgery, Tissue Engineering

For More Information Contact:  Khunkhun, Rajinder

 

Invention Description:

Drs. Mauney and Estrada have developed a method of engineering a synthetic biomaterial to support the regeneration of damaged tissues, particularly for use in the bladder. Inspired by the stem-cell scaffold work of Dr. Atala, formerly in Boston Children’s Urology Department, Dr. Mauney and Estrada sought an improved technique for treating bladders damaged by spina bifida, spinal cord injuries, multiple sclerosis, Parkinson’s and other diseases.


Utilizing a novel process for refining silk into a versatile biomaterial, the team has created a bi-layer silk scaffold, comprised of a foam layer that allows for ingrowth of host tissues and a non-porous layer that seals the wound site. The multi-layer scaffold technology is unique and provides the benefits of sealing fluid contents present in hollow organs at the time of surgical integration (non-porous barrier layer) while providing a porous layer for host tissue integration.


The material is capable of being fabricated into foams, weaves, meshes or scaffolds, all of which have the capability of being elastic, porous, or stiff for maximum effectiveness and a wide variety of use cases. Importantly, the material is ascellular, which means it can be used “off the shelf” and avoids the barriers inherent with cell-seeded constructs. The material is also inert and biodegradable, which will encourage the growth of new tissue and could eliminate the need for additional surgeries.


Preliminary results in a porcine model of augmentation cytoplasty have demonstrated remarkable support of regeneration of innervated, vascularized smooth muscle and urothelial tissues with structural, mechanical, and functional properties comparable to native tissue. This invention has the potential to replace the current technique for bladder augmentation, which includes a complex, open procedure in which a portion of the intestine or stomach is attached to the bladder as a patch.

Applications:

A silk-based scaffold for the regeneration of damaged bladder tissue, with potential uses for urethra, esophagus, trachea or other hollow organs, as well as wound healing in general.

Competitive Advantages:

• Considerably less invasive and risky than enterocytoplasty

• Biodegradable material encourages growth and eliminates the need for additional surgeries

• Potential applications across a variety of organs

• B. mori derived silk is a natural polymer with centuries of biomedical applications that does not elicit an immunogenic response

Key Publications: Tu DD, Chung YG, Gil ES, Seth A, Franck D, Cristofaro V, Sullivan MP, Di Vizio
D, Gomez P 3rd, Adam RM, Kaplan DL, Estrada CR Jr, Mauney JR. Bladder tissue regeneration using acellular bi-layer silk scaffolds in a large animal model of augmentation cystoplasty. Biomaterials. 2013 Nov;34(34):8681-9. doi:
10.1016/j.biomaterials.2013.08.001. Epub 2013 Aug 13. PubMed PMID: 23953839


Chung YG, Tu D, Franck D, Gil ES, Algarrahi K, Adam RM, Kaplan DL, Estrada CR
Jr, Mauney JR. Acellular bi-layer silk fibroin scaffolds support tissue regeneration in a rabbit model of onlay urethroplasty. PLoS One. 2014 Mar 14;9(3):e91592. doi: 10.1371/journal.pone.0091592. eCollection 2014. PubMed PMID: 24632740

IPStatus: Pat. Pend.