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

September 22, 2023 updated by: Harvard Apparatus Regenerative Technology, Inc.

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 single 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shunfu Hu, Phd.
  • Phone Number: 774.233.7341
  • Email: shu@hregen.com

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Andrew Chang, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Dennis Wigle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 > 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, at least 4 cm above gastroesophageal junction (GEJ) and at least 4 cm below the larynx
  6. Patient must be a high-risk candidate for minimally invasive esophageal reconstruction, based upon the investigator's determination (For example, laparoscopic gastric pull-up (GPU) is not an option 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

Exclusion Criteria:

  1. 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).
  2. Known clinical contraindication that would obfuscate the use of the covered metallic stent to be used as an adjunct to the procedure
  3. Post ablation stricture for Barrett's esophagus treated less than 1 year prior to planned procedure

  4. 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 (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
  5. Life expectancy of less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short Segment Esophageal Replacement
Combination product: 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 stromal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients who develops continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.
Time Frame: 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.
Month 3
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
Time Frame: 42 days
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
42 days
The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure
Time Frame: 42 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).
42 days
Number of participants experiencing death within 30 days of index procedure
Time Frame: Within 30 days
Number of participants experiencing death within 30 days of index procedure
Within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Apparatus Regenerative Technology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSTG-CEI-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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