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A retrievable autologous bioengineered esophageal implant as a novel treatment for long-gap esophageal atresia

Award Number: R44HD095784
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 11/01/2018
PERIOD OF PERFORMANCE END DATE: 09/30/2021

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A retrievable autologous bioengineered esophageal implant as a novel treatment for long-gap esophageal atresia - Esophageal Atresia (EA) is a congenital birth defect characterized by a discontinuity of the esophagus. Each year several thousand children are born within the EA spectrum. Babies born with EA have trouble feeding, and require a procedure to correct the abnormality. The best treatment for EA is surgery reconnecting the two ends of the esophagus to each other. In some children, however, the gap between the two esophageal ends is too long to be easily connected. This condition is known as long-gap esophageal atresia (LGEA). Current surgical options available for the treatment of LGEA focus upon either the replacement of the esophageal tissue with other autologous tissue, or mechanically stretching the current esophageal tissue to bridge the gap. Although there are several techniques available, there is little consensus about the optimal repair of LGEA. In addition, the infrequent occurrence of LGEA also means that development of improved techniques is greatly hampered. Thus, there is clearly an unmet clinical need for effective methods of esophageal repair. To answer this unmet medical need, Biostage Inc and our academic partners at Connecticut Children’s Medical Center (CT Children’s) propose to develop a novel tissue-engineered esophageal implant that combines a synthetic scaffold with patient derived stem cells, as a treatment for LGEA. Biostage's Cellspan Esophageal Implant has the unique ability to induce the body's own repair mechanism, while providing spatial cues to assist regeneration. Previous preclinical studies at Biostage have established that full-thickness circumferential esophageal defects can be treated by implanting the CEI in an adult pig model. Studies at the Finck laboratory have shown that autologous epithelial cell seeded scaffold can be utilized to treat similar defects in a piglet model. Based on these findings we plan to develop a novel tissue engineered esophageal implant to address LGEA in newborns. The goal of the project will be establishing long-term efficacy of our CEI as an esophageal replacement in piglet pediatric model. Phase I will include the preparation of CEI with size relevant for a pediatric model (Specific Aim #1). We will create a CEI by seeding piglet cells on 3D scaffold in bioreactor and analyze the CEI to determine cell viability, cell penetration and cell functionality in terms of MSC marker expression and cytokine secretion profiles. In Phase II we will perform a short-term in vivo feasibility study of CEI as an esophageal replacement in a piglet model (Specific Aim #2). Once we confirm that no acute adverse effects arise due to animal exposure to the CEI, we will conduct a long term in vivo study (Specific Aim #3), where we will follow the growth and development of the tissue in the implant zone. The ability of the animals to function normally at such longer time scales will be key to assess the use of the CEI as an esophageal treatment. Upon completion of these Aims, we will initiate dialogue with the FDA to obtain pre-IND guidance and will carry out pre-clinical studies to ensure a clinical path for the use of CEIs as a treatment for pediatric atresia.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = -$340,069 )
2023	2020	BIOSTAGE, INC.	84 OCTOBER HILL RD STE 11	HOLLISTON	MA	01746	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	3	10/24/2022	NON-COMPETING CONTINUATION	-$340,069
														Subtotal = -$340,069

Issue Date FY: 2020 ( Subtotal = $498,749 )
2020	2020	BIOSTAGE, INC.	84 OCTOBER HILL RD STE 11	HOLLISTON	MA	01746	MIDDLESEX	USA	Child Health and Human Development Extramural Research	002	3	8/3/2020	NON-COMPETING CONTINUATION	$498,749
2020	2019	BIOSTAGE, INC.	84 OCTOBER HILL RD STE 11	HOLLISTON	MA	01746	MIDDLESEX	USA	Child Health and Human Development Extramural Research	001	2	1/23/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
2020	2018	BIOSTAGE, INC.	84 OCTOBER HILL RD STE 11	HOLLISTON	MA	01746	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	1	1/23/2020	NEW	$0
														Subtotal = $498,749

Issue Date FY: 2019 ( Subtotal = $1,103,346 )
2019	2019	BIOSTAGE, INC.	84 OCTOBER HILL RD STE 11	HOLLISTON	MA	01746	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	2	10/26/2018	EXTENSION WITH OR WITHOUT FUNDS	$1,103,346
														Subtotal = $1,103,346

Issue Date FY: 2018 ( Subtotal = $224,615 )
2018	2018	BIOSTAGE, INC.	84 OCTOBER HILL RD STE 11	HOLLISTON	MA	01746	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	1	3/28/2018	NEW	$224,615
														Subtotal = $224,615

Grand Total All Awards = $1,486,641

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A retrievable autologous bioengineered esophageal implant as a novel treatment for long-gap esophageal atresia

Award Number: R44HD095784

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 11/01/2018

PERIOD OF PERFORMANCE END DATE: 09/30/2021

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