Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
Condition: Esophageal Diseases · Sponsor: Harvard Apparatus Regenerative Technology, Inc.
About this study
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.
This description comes directly from the study's public registry record.
Talk to the study team
Shunfu Hu, Phd. · 774.233.7341 · shu@hregen.com
William L Fodor, Ph.D. · 203-605-8103 · wfodor@hregen.com
Always discuss trial participation with your own doctor first.
Locations (3)
| Keck Medical Center of University of Southern California | Los Angeles, California, United States | Recruiting |
| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05877300