Cellspan™ Esophageal Implant-Adult (CEI)
The CEI is a combination product consisting of an engineered synthetic scaffold (device constituent) seeded and cultured with the patient's adipose derived mesenchymal stem cells (biologic constituent), intended to stimulate regeneration of a structurally intact, living biologic esophageal conduit, in patients requiring full circumferential esophageal reconstruction up to 6 cm segment in length.
This is a dual arm, unblinded, multicenter, prospective first-in-human (FIH) feasibility study to be performed at a maximum of 5 centers in the United States with a maximum of 10 subjects in total. All subjects will be followed for a minimum of 2 years post-implant surgery.
Since this is an FIH experience, the study will utilize an independent Data Monitoring Committee (DMC) to evaluate safety on a continuous basis to mitigate any safety risks to subjects. A sentinel approach to enrollment of subjects shall be guided by the DMC review of cases.
Subject ≥18 years of age
Refractory benign esophageal strictures (RBES)
Esophageal perforation (full thickness)
Chronic/persistent esophageal fistula
Subject requires or undergoes an esophageal segmental excision >6 cm in length
Esophageal segment extends below the diaphragm or <4 cm below larynx
Pre-existing implants/structures adjacent to target surgical location for implant that could cause abrasion of the scaffold/regenerated tissue (e.g., pacemaker lead, vascular clips, vascular grafts).
Known clinical contraindication that would obfuscate the use of the covered metallic stent to be used as an adjunct to the procedure