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
Parallel
CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus
Combination productThe CEI will be surgically implanted using standard thoracotomy techniques for esophageal reconstruction. Day 0 procedures include: a short segment esophageal resection up to 6 cm, CEI implantation with end-to-end anastomosis, placement of a covered metallic stent, securing the stent with sutures, measuring and recording the stent position, placing draining catheters, inserting a dual lumen gastric-jejunal feeding tube, and conducting hematology and serum tests. A baseline CT/MRI scan will be performed post-surgery to check the anastomotic sites and stent placement.
CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy
Combination productFor CEI grafts extending the upper esophagus from the neck ostomy, the patient is positioned supine to expose the left neck and upper chest. A neck incision is made medial to the sternocleidomastoid muscle. The distal esophagus at the cervical spit fistula is freed and mobilized. The CEI is connected to the mobilized esophageal segment with absorbable sutures. Photos document the new spit fistula length post-graft. A new spit fistula tunnel is created on the anterior chest wall, preserving skin and tissue. A covered metallic stent is placed endoscopically through the spit fistula into the CEI, secured with sutures. Pre-surgery tests include hematology, serum chemistry, urinalysis, and CRP, with CRP checked on Days 3 and 5 post-surgery. A CT or MRI scan is done on days 3-7 post-surgery to establish a baseline for tissue deposition analysis around the CEI.
Cohort 1: The number of patients who develop continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.
The number of patients who develops continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation, prior to or at Month 3 visit (Day 77 ±10) following implantation.
All Cohorts: The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
All Cohorts: The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure
The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure (gastric pull-up, colonic interposition, or other surgical reconstruction).
All Cohorts: Number of participants experiencing death within 30 days of index procedure
Number of participants experiencing death within 30 days of index procedure
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