Intestinal lengthening via distraction enterogenesis for the treatment of short bowel syndrome
Active Project Grant Awarded Last action
- Award ID
- R44DK127658
- Recipient
-
Eclipse Regenesis, Inc. UEI NNJ5XHMGNKS8
- Awarding agency
-
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health, Department of Health and Human Services
- Obligated
- $4,894,640
Award facts
- Assistance listing
- 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research
- Completion date 75% complete
- Originally
- Funding
-
- $4,471,419.00 Federal
- $423,221.00 Non-federal
- Place of performance
- Mountain View, CA 94040, USA
Award details come from USAspending.gov.
Description
- Abstract
- Short bowel syndrome (SBS) is a rare, chronic, and devastating malabsorption condition where patients are unable to absorb enough nutrients naturally to sustain life. This condition is due to the loss of the majority of their small intestine from a massive surgical resection necessitated by certain diseases that destroy the small intestine. In the pediatric patient population, the most common diseases that lead to SBS are necrotizing enterocolitis, midgut volvulus, and intestinal atresia. In the adult population, diseases include crohn's, cancer, intestinal ischemia, and trauma. These conditions all result in the need for a massive resection of the small intestine leaving the patient without enough functional small intestine to absorb nutrients naturally. Current chronic therapies for SBS include, parenteral nutrition, expensive daily medication and intestinal surgery, which come at a staggering average 5-year cost of $1.6M per patient. IT is estimated that the first year of treatment for a pediatric SBS patient is in excess of $500,000. Complications from daily parenteral nutrition include liver failure and central line infections (SEPSIS). Mortality rates as high as 30% by age 5 have been reported and none of the currently available treatments for SBS restore natural absorption of nutrients. Over the last decade, intestinal lengthening via distraction enterogenesis has emerged as a potential restorative treatment option for patients with short bowel syndrome. Preclinical research has shown that mechanical distraction devices can stimulate the growth of healthy small intestine tissue in multiple animal models. Literature has shown that for every additional 1% of expected small bowel a child possesses, the odds of weaning from parenteral support increases by 3% (belza ET AL, 2019). The goal of this project is to move this emerging technology from the lab to the bedside by completing an FDA requested pre-clinical study, receiving IDE approval, and conducting a first-in-human clinical trial. The phase I portion of the project will produce the pre-clinical safety data on the final design of the eclipse XL1 distraction enterogenesis device required for FDA IDE submission. Based on feedback from the FDA, phase II will produce the first in human clinical trial data in a stepwise fashion to ensure safety and probable benefit. If successful, this novel treatment will revolutionize the care of SBS patients and potentially return them to enteral autonomy.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | $860,948 | $0 | |
| Amendment | $856,731 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
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| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $813,592 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $546,853 | $0 | |
| Amendment | $546,853 | $0 | |
| Amendment | $423,221 | $0 | |
| Original award | $423,221 | $423,221 |
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Quick answers
Who received award R44DK127658?
R44DK127658 was awarded to Eclipse Regenesis, Inc. by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on July 12, 2021.
How much is award R44DK127658 worth?
$4,894,640 has been obligated on R44DK127658: $4,471,419 in federal funding and $423,221 in non-federal funding.
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