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Tests treatment safety and results for Esophageal Diseases
Official title Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
ClinicalTrials.gov ID: NCT05877300
What this study is testing
What is CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus?
CEI Thoracic Surgical Implantation-Cellspan™ Esophageal Implant-Adult (CEI) in patients requiring a full reconstruction of the esophagus is an investigational medicine, being studied as a potential treatment for esophageal diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cohort 1:
- 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)
You likely can't join if
- all cohorts:
- Subject requires or undergoes an esophageal segmental excision \>6 cm in length
- Esophageal segment extends below the diaphragm or \<4 cm below larynx
- Pre-existing implants/structures adjacent to target surgical location for implant that could cause abrasion of the scaffold/regenerated tissue (e.g...
- 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
See the full eligibility criteria
Who can join
- Cohort 1:
- 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...
- 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, above the diaphragm and at least 4 cm below the larynx.
- 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...
- 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
- The patient/guardian is willing and able to comply with the protocol specified medication regimen and follow-up evaluations
- 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...
- Subject ≥18 years of age
- The patient has medical conditions requiring esophageal reconstruction, limited to: a. Spit Fistula with an upper esophageal ostomy in the neck
- Patients may require esophageal de-functioning with a resulting cervical spit fistula if they are not candidates for immediate esophageal reconstruction. This may occur for multiple reasons, including being too sick for...
- The patient must be a surgical candidate for a short segment esophageal reconstruction (\< 7cm), a full circumferential segmental esophageal extension in order to have sufficient length to make the anastomosis to the...
- Patient must be a high-risk candidate for the standard of care treatment of esophageal reconstruction, based upon the investigator's determination. The patient requires a thoracotomy to repair the esophagus following...
- All patients must be made aware and must be amenable to a delayed rescue repair surgical procedure in the event the CEI fails to mature in the subdermal area prior to mobilization
- The patient/guardian is willing and able to comply with the protocol- specified medication regimen and follow-up evaluations
- 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...
What rules you out
- all cohorts:
- Subject requires or undergoes an esophageal segmental excision \>6 cm in length
- Esophageal segment extends below the diaphragm or \<4 cm below larynx
- 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...
- diabetes mellitus (CCI = 1)
- connective tissue disorders (CCI=1)
- immune compromised
- chemotherapy radiotherapy or chemoradiotherapy (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
- 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)...
- 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
- 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...
- Patient with an infection requiring antibiotic therapy
- Known allergy to Nitinol (for adjunctive self-expanding covered metallic stent procedure)
- Current participation in another investigational drug or device study
- Patient is a prisoner
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.