Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
1 other identifier
interventional
10
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2023
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedStudy Start
First participant enrolled
July 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 11, 2026
October 1, 2025
3 years
May 5, 2023
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Cohort 1: The number of patients who develop continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.
The number of patients who develops continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation, prior to or at Month 3 visit (Day 77 ±10) following implantation.
Month 3
All Cohorts: The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
42 days
All Cohorts: The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure
The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure (gastric pull-up, colonic interposition, or other surgical reconstruction).
42 days
All Cohorts: Number of participants experiencing death within 30 days of index procedure
Number of participants experiencing death within 30 days of index procedure
Within 30 days
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
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
Month 3
Study Arms (2)
Short Segment Esophageal Replacement in patients requiring a full reconstruction of the esophagus
EXPERIMENTALShort Segment Esophageal Replacement in patients that have had a previous partial esophagectomy
EXPERIMENTALInterventions
For CEI grafts extending the upper esophagus from the neck ostomy, the patient is positioned supine to expose the left neck and upper chest. A neck incision is made medial to the sternocleidomastoid muscle. The distal esophagus at the cervical spit fistula is freed and mobilized. The CEI is connected to the mobilized esophageal segment with absorbable sutures. Photos document the new spit fistula length post-graft. A new spit fistula tunnel is created on the anterior chest wall, preserving skin and tissue. A covered metallic stent is placed endoscopically through the spit fistula into the CEI, secured with sutures. Pre-surgery tests include hematology, serum chemistry, urinalysis, and CRP, with CRP checked on Days 3 and 5 post-surgery. A CT or MRI scan is done on days 3-7 post-surgery to establish a baseline for tissue deposition analysis around the CEI.
The CEI will be surgically implanted using standard thoracotomy techniques for esophageal reconstruction. Day 0 procedures include: a short segment esophageal resection up to 6 cm, CEI implantation with end-to-end anastomosis, placement of a covered metallic stent, securing the stent with sutures, measuring and recording the stent position, placing draining catheters, inserting a dual lumen gastric-jejunal feeding tube, and conducting hematology and serum tests. A baseline CT/MRI scan will be performed post-surgery to check the anastomotic sites and stent placement.
Eligibility Criteria
You may qualify if:
- 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 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
- 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 laparoscopic or robotic minimally invasive gastric pull-up (GPU) surgery, 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
- +11 more criteria
You may not qualify if:
- 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 Comorbidities Index (CCI, Yamashita 2018) scoring system and include:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Keck Medical Center of University of Southern California
Los Angeles, California, 90033, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2023
First Posted
May 26, 2023
Study Start
July 13, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 11, 2026
Record last verified: 2025-10