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NIH Award Supports Esophagus Tissue Implants from Stem Cells

Newborn

(Petr Kratochvil, Public Domain Pictures)

6 Nov. 2018. A company developing engineered tissue implants from stem cells received a grant from National Institutes of Health to develop an implant to correct a congenital defect in a newborn infant’s esophagus. The $1.1 million small business grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of NIH, was awarded to Biostage Inc. in Holliston, Massachusetts.

The award to Biostage funds development of implanted tissue derived from the stem cells to repair esophageal atresia, a congenital defect in some newborn infants. In esophageal atresia, a baby is born with a gap between the upper and lower esophagus that impairs feeding and can cause coughing, gagging, or choking. The company cites data showing the condition occurs in approximately 1 in 2,500-3,500 live births.

According to Biostage, current techniques for correcting the defect include taking tissue from another part of the body, such as the stomach, or stretching the existing upper and lower esophagus to connect the two ends. In babies where the gap is too large, the second option is not available.

Biostage proposes a different strategy to fix the defect, by growing new esophagus tissue from the baby’s stem cells. The company’s Cellframe process takes stem cells from a sample of person’s adipose, or fat, tissue. The stem cells are multiplied and seeded on an electrospun polyurethane scaffold or matrix. The seeded scaffold is then placed in a bioreactor for several days to allow replacement tissue to grow. The resulting Cellspan tissue implant is surgically reconnected in the patient, which provides natural signals for further growth and regeneration, with the scaffold later removed.

As reported in the journal Nature Scientific Reports in March, as well as Science & Enterprise, Biostage successfully tested the process in adult pigs who have digestive organs, including the esophagus, similar to size to humans. That same month, the company received an initial award of $225,000 from NIH to show the technical feasibility of Cellspan esophageal implants in piglets.

The new award funds a 2-year preclinical project first testing the short-term safety and tolerability of implanting Cellspan esophageal implants in piglets, looking primarily for adverse effects. The study then will assess the longer-term viability of the implants to grow new esophagus tissue in the piglets, and to allow the piglets to function normally. The results are expected to help the company file for an investigational new drug application to the Food and Drug Administration, requesting clearance to begin clinical trials.

Christine Finck, chief surgeon at Connecticut Children’s Hospital in Hartford and on the pediatrics faculty at University of Connecticut says in a company statement, “There is a tremendous unmet medical need for children suffering with esophageal atresia in the United States and across the world.  This technology has the potential to dramatically improve their care and condition.” Finck is a scientific adviser to Biostage and co-principal investigator on the project with Sumati Sundaram, the company’s director of cell biology.

The grant was awarded under NIH’s Small Business Innovation Research program that sets aside funding for small, early-stage businesses in the health care and life science fields. In the last (2018) fiscal year, NIH channeled more than $1 billion into its small business set-aside programs.

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