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NCT05877300 | Recruiting | Esophageal Diseases

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

Harvard Apparatus Regenerative Technology, Inc.

Brief 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 single 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.

Condition or disease

Esophageal Diseases

Intervention/treatment

Cellspan™ Esophageal Implant-Adult (CEI)

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 10 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
Actual Study Start Date : July 13, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : December 2026
Arm Intervention/treatment

Experimental: Short Segment Esophageal Replacement

Combination Product: Cellspan™ Esophageal Implant-Adult (CEI)
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Subject ≥18 years of age
  • The patient has medical conditions requiring esophageal reconstruction, such as, but not limited to
    • Refractory benign esophageal strictures (RBES)
    • Esophageal perforation (full thickness)
    • Chronic/persistent esophageal fistula
    • 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).
    • a. If RBES: i. Steroid treatment ii. Esophageal balloon dilation (EBD) iii. Stent use >6 months iv. Endoscopic incisional repair
    • b. If esophageal perforation: i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent > 6 months iv. Primary surgical repair
    • c. If Chronic/Persistent fistula(e): i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent > 6 months iv. Primary surgical repair
    • d. If Combination Perforation/fistula with RBES i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent use > 6 months iv. Primary surgical repair
    • The patient must be a surgical candidate for a short segment esophageal reconstruction (<6 cm full circumferential segmental excision)
    • The location of the esophageal segment for surgical resection is within the thoracic cavity, defined as, at least 4 cm above gastroesophageal junction (GEJ) and at least 4 cm below the larynx
    • Patient must be a high-risk candidate for minimally invasive esophageal reconstruction, based upon the investigator's determination (For example, laparoscopic gastric pull-up (GPU) is not an option due to a medical contraindication)
    • All patients must be made aware and must be amenable to a delayed rescue repair surgical procedure in the event the CEI fails to restore a patent durable biologic esophageal conduit
    Exclusion Criteria
    • 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
      • diabetes mellitus (CCI = 1)
      • connective tissue disorders (CCI=1)
      • immune compromised
      • chemotherapy (within 60 day clearance)
      • inability to tolerate major thoracotomy
      • active infection at the biopsy or thoracotomy incision site
      • peripheral vascular disease (CCI=1)
      • all patients with a CCI> 2
      • Life expectancy of less than 1 year
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement

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

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Locations

Recruiting

United States, road cancer

University of Michigan

Ann Arbor, road cancer, United States, 48109

Recruiting

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905