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NCT05877300 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
A Phase 1 study of Esophageal Diseases, sponsored by Harvard Apparatus Regenerative Technology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT05877300: Recruiting Phase 1 study of Esophageal Diseases, sponsored by Harvard Apparatus Regenerative Technology.
NCT05877300 is a Phase 1 study of Esophageal Diseases that is actively recruiting participants, run by Harvard Apparatus Regenerative Technology. The registered enrollment target is 10 participants, below the 19,519-participant average among 5 other Esophageal Diseases trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05877300, a Phase 1 study of Esophageal Diseases, is actively recruiting participants, sponsored by Harvard Apparatus Regenerative Technology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus
- COMBINATION_PRODUCT CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy
Study Locations (3)
California
- Keck Medical Center of University of Southern California - Los Angeles
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-07-13 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05877300 shows while recruiting
NCT05877300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 19,519-participant average among 5 other Esophageal Diseases trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Esophageal Diseases appearing as the primary indexed condition, and to 2 interventions - of which CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus is the first listed.
NCT05877300 reports a single indexed study location in California, Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05877300 about?
NCT05877300 is a clinical study titled "Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement". 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 in...
What is the current status of trial NCT05877300?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-07-13. Estimated completion is 2026-12.
What conditions does trial NCT05877300 study?
This clinical trial studies the following conditions: Esophageal Diseases.
What interventions are being tested in trial NCT05877300?
The interventions under investigation include: CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus (COMBINATION_PRODUCT), CEI Extra-Thoracic Subdermal Surgical Implantation - Cellspan™ Esophageal Implant-Adult (CEI) in patients that have had a previous partial esophagectomy (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05877300?
This trial is sponsored by Harvard Apparatus Regenerative Technology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05877300 being conducted?
This trial has 3 study locations across California, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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