Hregen

Connect with us:
SIGN UP
Menu
Connect with us:
SIGN UP
Menu
Connect with us:
SIGN UP
Connect with us:
SIGN UP
Menu
Menu
Addressing life-threatening conditions of the esophagus, bronchus
Congential defects, trauma and cancers of the esophagus, bronchi have a devastating impact on patients. Unfortunately, the current treatment options, when available, carry a significant mortality and morbidity rate, and can drastically reduce the quality of life. For the first time, HRGN is developing radically new ways to treat these life-threatening conditions. Clinical trials are being designed with the potential to demonstrate improved mortality rates, reduced complications, and enhanced patient quality of life.
Esophageal Cancer: A Deadly Disease

Esophagectomy, the current standard of care for resectable esophageal cancer, is a complex surgical resection requiring stomach “pull-up” or the use of an intestinal segment that is resected with its arteries and veins and then repositioned in the chest to become the replacement esophagus. Esophagectomy, followed by stomach “pull-up” or intestinal interposition, carries a mortality rate at 90 days that can be as high as 19%. Post-operative complications may be life threatening. The most serious are pulmonary complications like respiratory failure and pneumonia, followed by leakage of gastrointestinal fluid in the chest from the place where the esophagus is surgically connected with the stomach or the intestine, which in turn can also lead to serious infections.

Central Lung Cancer: Isolated in the Bronchus

In lung cancer, although none of the four main cell types is exclusively central or peripheral in location, the majority of small-cell lung cancers and squamous cell carcinomas are centrally located in the bronchi. When the cancer affects the main bronchi or the tracheal bifurcation (carina), a pneumonectomy, the removal of an entire lung, may be necessary which reduces respiratory capacity by 50% and has a complication rate up to 50% and a post-surgical mortality rate of 8% to 15%. HRGN’s Cellspan bronchial implants are intended to preserve the lung enabling safe reattachment of the main airway.

Tracheal Cancer and Trauma: Limited Treatment Options

In tracheal cancer and trauma, when there is extensive damage to the trachea, currently there is no standard technique that allows to preserve tracheal length and function following resection, leading to high rates of complications and mortality. HRGN’s tracheal implants are intended to reduce complications and cost.

Esophageal Atresia

A Life-Threatening Condition and Unmet Medical Need

Esophageal Atresia (EA) is a devastating congenital defect that causes infants to be born with a gap between their esophagus and stomach. Worldwide, EA occurs in approximately 1 in 2,500-3,500 live births. Although the disorder is most often detected right after birth when the baby is unable to feed properly, it is sometimes possible to detect the condition by ultrasound as evidenced by an abundance of amniotic fluid. Currently there are no disease dedicated treatments for EA. Current protocol is surgery to close the gap. This can be done in some cases by reattaching the two ends together. In many cases the only option is to anatomically replace the missing esophagus either by pulling up the stomach or by using a section of the gastrointestinal tract. Any of these surgical techniques of esophageal replacement are plagued by complications, like anastomotic leaks and scaring strictures that require further treatments. HRGN is developing a Cellspan Implant that can be used as an esophageal substitute. This replacement implant is combined with a baby’s own stem cells aims to avoid the use of the baby’s stomach or intestine with the goal of improving short- and long-term outcomes.

What is Esophageal Atresia?

Learn more about this life-threatening congenital abnormality.

The Cellspan Esophageal Implant

Designed to bridge the gap between two portions of the esophagus.

HRGN's Focus: Esophageal Atresia

A large unmet medical need for patients and their families.

Reproducibility of the Cellspan Esophageal Implant

Preclinical studies demonstrate consistent regeneration is feasible.

Digestive Tract Disorders

Harvard App Regen Tech is also exploring the use of the Cellspan Technology to repair other tubular organ structures in the digestive tract. Small and large bowel disorders in the US. Including, cancer, diverticulitis, Crohn’s Disease, Inflammatory bowel disease, stenosis and bowel obstructions resulted in 1.8 million hospital visits costing the US health care system ~$30B1 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/patient1 with an annual overall cost to the health care system of $1B.
 
1 Peery et. al. 2022. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2021. Gastroenterology; 162, 621.

Reproductive Tract Disorders (Women’s Health and Reproduction or Patch Technology or Uterine Repair)

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.

Reproducibility of the Cellspan Esophageal Implant

Preclinical studies demonstrate consistent regeneration is feasible.
Cellspan Esophageal Implant Technology
At the forefront of tissue engineering and regenerative medicine.
Harvard Apparatus Regenerative Technology (formerly Biostage Inc.)
References

Alifino et al. Sleeve Pneumonectomy, Multi-Media Journal of Cardio-Thoracic Surgery, Jan. 2007 doi: 10.1510/mmcts.2006.002113.

American Cancer Society. Esophagus cancer. Atlanta, GA 2014.

Ferguson MK, Celauro AD, Prachand V. Prediction of major pulmonary complications after esophagectomy. Ann Thorac Surg. 2011;91:1494-1501.

In H, Palis BE, Merkow RP, et al. Doubling of 30-day mortality by 90 days after esophagectomy. Ann Surg. 2016;263(2):286-291.

International Agency for Research on Cancer. Oesophageal cancer: estimated incidence, mortality and prevalence worldwide in 2012. GLOBOCAN 2012 2012:http://globocan.iarc.fr/Pages/fact_sheets_cancer. Aspx?cancer=oesophagus. Accessed December 1, 2015.

Lightdale CJ. Practice guidelines: Esophageal cancer. Am J Gastroenterol. 1999;94(1):20-29.

Livstone EM. Esophageal cancer. Merck Manual Professional Version July 2014; http://www.merckmanuals.com/professional/gastrointestinal-disorders/tumo…. Accessed December 1, 2015.

Scarpa M, Valente S, Alfieri R, et al. Systematic review of health-related quality of life after esophagectomy for esophageal cancer. World J Gastroenterol. 2011;17(42):4660-4674.

van Hagen P, Hulshof MCCM, van Lanschot JJB, et al. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012;366:2074-2084.