Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short… (NCT05877300) | Clinical Trial Compass
RecruitingPhase 1
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
United States10 participantsStarted 2023-07-13
Plain-language summary
Cellspanâ„¢ 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject ≥18 years of age
✓. The patient has medical conditions requiring esophageal reconstruction, such as, but not limited to:
✓. Combination of esophageal perforations/fistula with RBES
✓. The patient must have failed at least 3 previous treatment modalities to correct the medical esophageal condition (a-d).
✓. The patient must be a surgical candidate for a short segment esophageal reconstruction (≤6 cm full circumferential segmental excision)
Exclusion criteria
✕. Subject requires or undergoes an esophageal segmental excision \>6 cm in length
✕. Esophageal segment extends below the diaphragm or \<4 cm below larynx
What they're measuring
1
Cohort 1: The number of patients who develop continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.
Timeframe: Month 3
2
All Cohorts: The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
Timeframe: 42 days
3
All Cohorts: The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure
Timeframe: 42 days
4
All Cohorts: Number of participants experiencing death within 30 days of index procedure
Timeframe: Within 30 days
5
Cohort 2: The number of patients with maturation of the CEI graft under the dermal layer followed by mobilization and connection to the distal esophagus within the thoracic cavity to form a continuous biologic neo-conduit based on endoscopic evaluation
Timeframe: Month 3
Trial details
NCT IDNCT05877300
SponsorHarvard Apparatus Regenerative Technology, Inc.
✕. 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
✕. Post ablation stricture for Barrett's esophagus treated less than 1 year prior to planned procedure
✕. Patient has a comorbidity or contraindication that would preclude any study required procedures including adipose tissue biopsy and esophageal resection surgery. Comorbidities are defined from a subset of the Charlson Comorbidities Index (CCI, Yamashita 2018) scoring system and include: