Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement

Part of paid clinical trials in Los Angeles, California.

Sponsor
Harvard Apparatus Regenerative Technology, Inc.
Study ID
NCT05877300
Phase
PHASE1
Status
Recruiting
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Conditions

  • Esophageal Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus — COMBINATION_PRODUCT
    The 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_PRODUCT
    For 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.

Study Details

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.

Key Dates

Start date
Jul 13, 2023
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Short Segment Esophageal Replacement in patients requiring a full reconstruction of the esophagus
  • Experimental: Short Segment Esophageal Replacement in patients that have had a previous partial esophagectomy

Primary Outcome Measure

Cohort 1: The number of patients who develop continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation. [ Time Frame: Month 3 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Keck Medical Center of University of Southern CaliforniaLos AngelesCalifornia90033
Stephanie Varela
[email protected]
323-442-6252
John Lipham, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Shari Barnett, RRT,CCRP,PMP
[email protected]
734-936-4561
Andrew Chang, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Karlyn Pierson, MAN.RN.CCRP
[email protected]
507-538-1960
Dennis Wigle, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Keck Medical Center of University of Southern California· Los Angeles, CAUniversity of Michigan· Ann Arbor, MIMayo Clinic· Rochester, MN

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