Actively Recruiting
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
Led by Harvard Apparatus Regenerative Technology, Inc. · Updated on 2026-03-11
10
Participants Needed
3
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18 years of age or older
- Medical condition requires esophageal reconstruction such as refractory benign esophageal strictures, esophageal perforation, chronic or persistent esophageal fistula, or a combination
- Patient has failed at least three previous treatment methods to correct the esophageal condition
- Patient is a surgical candidate for short segment esophageal reconstruction of 6 cm or less
- The esophageal segment for surgery is located in the thoracic cavity, above the diaphragm and at least 4 cm below the larynx
- Patient is high-risk for minimally invasive esophageal reconstruction and requires thoracotomy
- Patient is willing to accept a delayed rescue surgical repair if the implant fails
- Patient or guardian is able to comply with medication and follow-up requirements
- Patient or guardian has provided informed consent approved by an Institutional Review Board or Ethics Committee
You will not qualify if you...
- Esophageal segmental excision needed is greater than 6 cm in length
- Esophageal segment extends below the diaphragm or is less than 4 cm below the larynx
- Presence of implants or structures near the surgical site that may damage the scaffold or tissue
- Clinical contraindications to using the covered metallic stent
- Post ablation stricture for Barrett's esophagus treated less than 1 year prior
- Comorbidities precluding study procedures, including diabetes, connective tissue disorders, immune compromise, recent cancer therapy, inability to tolerate thoracotomy, active infection at incision sites, peripheral vascular disease, or Charlson Comorbidity Index greater than 2
- Life expectancy less than 1 year
- Pregnant or nursing, or plans to become pregnant within 1 year; females must have a negative pregnancy test within 7 days before surgery
- Untreated neurological, psychological, or psychiatric disorders interfering with study
- Immunodeficiency or therapies inhibiting cell growth within 30 days prior or planned post-implant
- Infection requiring antibiotic therapy
- Known allergy to Nitinol
- Current participation in another investigational study
- Patient is a prisoner
- Risk of opioid addiction from study-related pain management as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Keck Medical Center of University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
S
Shunfu Hu, Phd.
CONTACT
W
William L Fodor, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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