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

Description

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.

Conditions

Esophageal Diseases

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Esophageal Diseases
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subject ≥18 years of age
  • 2. The patient has medical conditions requiring esophageal reconstruction, such as, but not limited to:
  • 1. Refractory benign esophageal strictures (RBES)
  • 2. Esophageal perforation (full thickness)
  • 3. Chronic/persistent esophageal fistula
  • 4. Combination of esophageal perforations/fistula with RBES
  • 3. The patient must have failed at least 3 previous treatment modalities to correct the medical esophageal condition (a-d).
  • 4. The patient must be a surgical candidate for a short segment esophageal reconstruction (\<6 cm full circumferential segmental excision)
  • 5. The location of the esophageal segment for surgical resection is within the thoracic cavity, defined as above the diaphragm and at least 4 cm below the larynx.
  • 6. 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)
  • 7. 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
  • 1. 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).
  • 2. Known clinical contraindication that would obfuscate the use of the covered metallic stent to be used as an adjunct to the procedure
  • 3. Post ablation stricture for Barrett's esophagus treated less than 1 year prior to planned procedure
  • 4. 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:
  • 1. diabetes mellitus (CCI = 1)
  • 2. connective tissue disorders (CCI=1)
  • 3. immune compromised
  • 4. chemotherapy (within 60 day clearance)
  • 5. inability to tolerate major thoracotomy
  • 6. active infection at the biopsy or thoracotomy incision site
  • 7. peripheral vascular disease (CCI=1)
  • 8. all patients with a CCI\> 2
  • 5. Life expectancy of less than 1 year

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Harvard Apparatus Regenerative Technology, Inc.,

Study Record Dates

2026-12