Study of the CELLSPAN Esophageal Implant (CEI) for Esophageal Reconstruction
This study is testing a new treatment called the CELLSPAN Esophageal Implant (CEI) for people who need part of their esophagus (the tube that carries food to your stomach) replaced. The CEI is a special implant made from a synthetic material combined with your own stem cells. The goal is to help your body grow a new, healthy esophageal tube. This is a first-time-in-human study, meaning it's the first time this implant is being used in people. Researchers want to see if the CEI is safe and if it can successfully help regenerate the esophagus. They will also check if patients develop complications like leaks or need emergency surgery. Up to 10 adults with certain esophageal conditions, such as severe scarring or holes, can join this study. The current status of the study is unclear.
- Study design
- This is a first-in-human feasibility study, meaning it's the first time this treatment is being tested in people. It is unblinded, so both you and the study team will know you are receiving the CEI. Up to 10 participants will be enrolled across multiple centers.
- What's involved
- You would undergo surgery to implant the CEI. You will then be followed for at least 2 years after the surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- All participants will be followed for a minimum of 2 years after the implant surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Cohort 1: The number of patients who develop continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.Month 3
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.
- All Cohorts: The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.42 days
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
- All Cohorts: The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure42 days
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).
- All Cohorts: Number of participants experiencing death within 30 days of index procedureWithin 30 days
Number of participants experiencing death within 30 days of index procedure
- 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 evaluationMonth 3
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