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Regeneration Across Multiple Indications

HRGN aims to change the treatment paradigm for patients suffering from life-threatening conditions of the esophagus, bronchus and trachea.

HRGN’s Cellframe/Cellspan technology utilizes a biocompatible scaffold that is seeded with the patient’s own cells to create a Cellspan implant.

Cellspan implants are being designed to provide a unique microenvironment that includes all the necessary cues to induce tissue formation: physical structures, chemical composition, surface properties, and, perhaps most importantly, biosignals that direct cell behaviors.

The Cellspan implant is delivered directly to the site where tissue regeneration is needed, and is intended to play a pivotal role in the success of in situ tissue regeneration by providing both stem cell-derived biological signals, and three-dimensional guidance and support, for cell growth and regeneration.In other words, Cellspan implants may provide instructive cues to cells in the patient’s surrounding tissue and stimulate responses in those cells that lead to tissue regeneration.As each organ has unique tissue structure, cell types and regenerative capacity, the design and properties of a Cellspan implant is unique for each indication or organ. Learn more about Cellspan product candidates in development for esophageal, bronchial and tracheal implants.

Digestive Tract

Colon
Colectomy is the partial or complete removal of the large intestine. It is a surgical procedure that is used to remove sections of the colon that are diseased (cancer, diverticulitis, Crohn’s Disease, Inflammatory bowel disease) or sections of the colon that become obstructed preventing the normal function of the digestive system. Following the removal of the damaged section of the colon, the heathy native portion of the tubular organ is reconnected to establish a continuous digestive tract. The incidence of colectomy in the US is approximately 300,000 cases annually. Complications associated with the procedure are primarily related to the reconnection site (anastomotic site) and include anastomotic leaks, stenosis (stricture formation), fistulas (holes that leak into the abdomen), infection, blood clots and necrosis (dead tissue resulting from poor circulation). Post-operative complications are well documented and approach 30% of procedures and account for up to 25% of all general surgery complications, costing, on average, 15,000-20,000/patient1with an annual overall cost to the health care system of $1B. Harvard Apparatus Regenerative Technology is developing 2 potential products to address the complication rates associated with anastomotic leaks and strictures that develop post-colonic resection.  We are currently testing these bio-device products in small animal models of colon resection through a collaboration with the McGowan Institute for Regenerative Medicine at the University of Pittsburgh.

1 Louis et.al. 2021. Financial Burden of post-operative complications following colonic resection. Medicine 100; e26546.

Reproductive Tract

In addition to our programs designed to treat tubular organ defects, we are also developing Patch Technologies that can be used to repair and rejuvenate non-tubular organs.  We have established a pre-clinical program through a collaboration with Yale University School of Medicine to test our Patch Technology in the female reproductive tract in a model of Intrauterine Adhesions (IUA, Asherman’s Syndrome). Intrauterine adhesions (IUAs) are considered one of the main reproductive system diseases in women worldwide, characterized by endometrial fibrosis with partial to complete obliteration of the uterine cavity and/or cervical canal. Any event that causes damage to the endometrium may lead to the development of IUAs, resulting in menstrual disturbances, infertility and (recurrent) pregnancy loss. IUAs have a debilitating impact on the health and quality of life in women of childbearing age while the economic burden is substantial. One of the leading causes of IUAs is the Dilation and Curettage (D&C) procedure that is performed following a miscarriage and for performing abortions. The incidence of IUAs ranges between 15% and 40% following a D&C procedure. According to the Center for Disease Control (CDC), there were 620,327 abortions in 20202 and based upon the frequency range of IUAs following a D&C procedure, the annual incidence of IUAs can range between 90,000-248,000. Harvard Apparatus Regenerative Technology is utilizing its proprietary scaffold technology in combination with stem cells to develop a temporary implant designed to inhibit IUAs by stimulating endometrial regeneration and healing post-Dilation and Curettage procedures. The technology is designed to be used either prophylactically or following laser ablation of existing IUAs.

2 Abortion Surveillance — United States, 2020 | MMWR (cdc.gov)