Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
Recruiting now · Phase 1
Conditions studied: Esophageal Diseases
In brief
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 facts
- Study ID
- NCT05877300
- Run by
- Harvard Apparatus Regenerative Technology, Inc.
- People needed
- 10
- Starts
- 2023-07-13
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Keck Medical Center of University of Southern California — Los Angeles, California, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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