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

Launched by HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. · May 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Cellspan Esophageal Implant (CEI) for patients who need surgery to replace part of their esophagus due to serious conditions. The CEI is designed to help the esophagus heal by using a special scaffold combined with the patient's own stem cells, which are cells that can develop into different types of tissue. The goal is to create a living replacement for the damaged part of the esophagus. The trial involves up to 10 patients and will take place at several medical centers in the U.S. Participants will be closely monitored for at least two years after their surgery to ensure their safety and to see how well the treatment works.

To be eligible for this trial, patients must be 18 years or older and have specific esophageal issues that have not responded to at least three previous treatments. They should also be candidates for surgery that involves removing a short segment of the esophagus, which is less than 6 centimeters long. Patients will need to understand that if the implant does not work as hoped, they may require additional surgery to fix the problem. This study is currently recruiting participants, and an independent committee will oversee the safety of everyone involved in the trial.

Gender

ALL

Eligibility criteria

• Inclusion 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).
• • 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 use ≥ 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
• • 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. The patient must be a high-risk candidate for minimally invasive esophageal reconstruction, based upon the investigator's determination. The patient requires a thoracotomy to repair the esophagus and is not amenable for laparoscopic or robotic minimally invasive gastric pull-up (GPU) surgery, 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
• • 8. The patient/guardian is willing and able to comply with the protocol specified medication regimen and follow-up evaluations
• • 9. The patient/guardian has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
• Exclusion Criteria:
• • 1. Subject requires or undergoes an esophageal segmental excision \>6 cm in length
• • 2. Esophageal segment extends below the diaphragm or \<4 cm below larynx
• • 3. 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).
• • 4. Known clinical contraindication that would obfuscate the use of the covered metallic stent to be used as an adjunct to the procedure
• • 5. Post ablation stricture for Barrett's esophagus treated less than 1 year prior to planned procedure
• 6. 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 radiotherapy or chemoradiotherapy (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
• • 7. Life expectancy of less than 1 year
• • 8. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7days prior to index procedure.
• • 9. Has a known untreated neurological, psychological, psychiatric, or other disorder that would interfere with trial endpoints or with cooperation with the requirements of the trial
• • 10. Has a diagnosis of immunodeficiency, receiving cancer therapy including chimeric antigen receptor T cells (CAR-T), receiving systemic steroid therapy (\>10 mg prednisone or equivalent daily dose), or any other form of pharmacologic therapy that would inhibit the intended cell growth (e.g., protease inhibitors, immunosuppressants, anti-cytokine therapies) within 30 days prior to index procedure or intended for use during any time after implantation through 12 months post-index procedure.
• • 11. Patient with an infection requiring antibiotic therapy
• • 12. Known allergy to Nitinol (for adjunctive self-expanding covered metallic stent procedure)
• • 13. Current participation in another investigational drug or device study
• • 14. Patient is a prisoner
• • 15. If in the opinion of the investigator, the patient requires pain management (potentially opioid medications) as a result of study participation, the patient is at an unreasonable risk of addiction. This decision may be based upon medical or social history, personal situation, or the expected time course, length, and type of medication use.