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

Primary Purpose

Esophageal Diseases

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cellspan™ Esophageal Implant-Adult (CEI)
Sponsored by
Harvard Apparatus Regenerative Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Diseases focused on measuring Esophagus, Esophagectomy, Tissue Engineering, Organ Regeneration, Regenerative Medicine, Cell Therapy, Single Arm, Unblinded, Multicenter, FIH, CEI, Biostage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 > 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, at least 4 cm above gastroesophageal junction (GEJ) and at least 4 cm below the larynx 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) 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: 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 (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

Sites / Locations

  • University of MichiganRecruiting
  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Short Segment Esophageal Replacement

Arm Description

Outcomes

Primary Outcome Measures

The number of patients who develops 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.
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.
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).
Number of participants experiencing death within 30 days of index procedure
Number of participants experiencing death within 30 days of index procedure

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
September 22, 2023
Sponsor
Harvard Apparatus Regenerative Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05877300
Brief Title
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
Official Title
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harvard Apparatus Regenerative Technology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Diseases
Keywords
Esophagus, Esophagectomy, Tissue Engineering, Organ Regeneration, Regenerative Medicine, Cell Therapy, Single Arm, Unblinded, Multicenter, FIH, CEI, Biostage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short Segment Esophageal Replacement
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Cellspan™ Esophageal Implant-Adult (CEI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of patients who develops continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.
Description
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.
Time Frame
Month 3
Title
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
Description
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
Time Frame
42 days
Title
The number of patients within the first 42 days that do not require a fall back emergency esophagectomy procedure
Description
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).
Time Frame
42 days
Title
Number of participants experiencing death within 30 days of index procedure
Description
Number of participants experiencing death within 30 days of index procedure
Time Frame
Within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 > 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, at least 4 cm above gastroesophageal junction (GEJ) and at least 4 cm below the larynx 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) 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: 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 (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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shunfu Hu, Phd.
Phone
774.233.7341
Email
shu@hregen.com
First Name & Middle Initial & Last Name or Official Title & Degree
William L Fodor, Ph.D.
Phone
203-605-8103
Email
wfodor@hregen.com
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shari Barnett, RRT,CCRP,PMP
Phone
734-936-4561
Email
shbailey@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Andrew Chang, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karlyn Pierson, MAN.RN.CCRP
Phone
507-538-1960
Email
pierson.karlyn@mayo.edu
First Name & Middle Initial & Last Name & Degree
Dennis Wigle, MD

12. IPD Sharing Statement

Learn more about this trial

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

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