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Stem Cell Fistula Plug in Post Surgical Leak Fistulas

Primary Purpose

Surgical Leak Fistula

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MSC Fistula Plug

About this trial

This is an interventional treatment trial for Surgical Leak Fistula

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Males and females 18-75 years of age.
Residents of the United States.
Patients with persistent symptomatic fistulas arising after gastro-esophageal resections, enteric or colonic resections or Bariatric surgeries.
Single-tract fistula
Have no contraindications to imaging evaluations: e.g. contrast allergies
Ability to comply with protocol
Competent and able to provide written informed consent
Must have failed standard conservative therapy which includes at least one endoscopic attempt to resolve fistula. Standard conservative management includes drainage of sepsis, antibiotics, nutritional support, etc. Endoscopic closure attempt with devices such as, but not limited to; endo-stitch, clipping, surgical sealants, etc. This attempt may be with or without diversion of the luminal contents by stenting.
Radiographic Imaging within 7 days of fistula plug placement (e.g. CT, PET, etc.).

Exclusion Criteria

Inability to give informed consent.
Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
Specific exclusions;
a. Evidence of hepatitis B, C, or HIV
Investigational drug within thirty (30) days of baseline
A resident outside the United States
History of clinically significant auto-immunity (i.e. Inflammatory Bowel Disease).
Previous allergic reaction to a fistula plug.
If obtaining sufficient adipose tissue for manufacturing is not technically feasible
Allergic to local anesthetics
Pregnant patients or trying to become pregnant or breast feeding.
Non-enterocutaneous tracts
Fistula output >2000 ml/day
Multiple or end fistulas
Fistulous tract <2 cm in length
Fistulous tract or defect >1 cm in diameter,
Fistulas opening into abdominal wall defect.
Diseased adjacent bowel, fistula in the radiation field, persistent distal obstruction or malignancy
Patients on immunosuppression or chemotherapy
Uncontrolled diabetes, i.e. blood sugar more than 200
Sepsis
Fistulas arising from a malignant lesion
Patients with obstructive malignancies
Patients with stage III and/or stage IV cancers. The investigators will exclude patients with stage III or IV cancers, poorly differentiated cancers and patients with less than accepted disease free surgical margins.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSC Fistula plug: Single Treatment Group

Arm Description

All patients received treatment of a stem cell coated fistula plug.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Data collection will include: worsening of the fistula, abnormal laboratory values, or significant abnormalities in physical examination. The Outcome Measure will be the number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Secondary Outcome Measures

Incidence of Fistula Closure

Data collection will include: degree of drainage cessation from fistula. The Outcome Measure will be the number of Participants With Closure of their Fistula.

Full Information

NCT ID

NCT02807389

First Posted

June 15, 2016

Last Updated

April 19, 2019

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02807389

Brief Title

Stem Cell Fistula Plug in Post Surgical Leak Fistulas

Official Title

A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Complicated Post-surgical Fistulas

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

March 14, 2017 (Actual)

Primary Completion Date

April 2, 2019 (Actual)

Study Completion Date

April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (The Gore Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients (age 18 and greater) with persistent symptomatic post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic therapies will be enrolled. The subjects will be subsequently followed for fistula response and closure for 18 months. This is an autologous product derived from the patient and used only for the same patient.

Detailed Description

Visit 1: Patients will be evaluated for eligibility (inclusion/exclusion checklist) and written, informed consent will be obtained. Patients will undergo general exam with vital signs. Patients will be scheduled for a fat biopsy to collect the tissue needed to grow MSC. In the event there is no cell growth from the tissue obtained from the first biopsy, one further attempt will made from a second tissue sample from this patient. However, if the second attempt fails to grow cells, no further attempts will be made, and the subject will not continue in the study. Visit 2 (Week 0; Day 0): Patients will undergo an interventional endoscopy, the fistula tract will be assessed and the stem cell coated will be placed endoscopically. Study visit will be as follows: Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (week 52; Month 12) Visit 10 (Week 78; Month 18)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Leak Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MSC Fistula plug: Single Treatment Group

Arm Type

Experimental

Arm Description

All patients received treatment of a stem cell coated fistula plug.

Intervention Type

Drug

Intervention Name(s)

MSC Fistula Plug

Other Intervention Name(s)

mesenchymal stromal cell coated fistula plug

Intervention Description

Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell.

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Time Frame

2-18 months

Secondary Outcome Measure Information:

Title

Incidence of Fistula Closure

Description

Data collection will include: degree of drainage cessation from fistula. The Outcome Measure will be the number of Participants With Closure of their Fistula.

Time Frame

2-18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Males and females 18-75 years of age. Residents of the United States. Patients with persistent symptomatic fistulas arising after gastro-esophageal resections, enteric or colonic resections or Bariatric surgeries. Single-tract fistula Have no contraindications to imaging evaluations: e.g. contrast allergies Ability to comply with protocol Competent and able to provide written informed consent Must have failed standard conservative therapy which includes at least one endoscopic attempt to resolve fistula. Standard conservative management includes drainage of sepsis, antibiotics, nutritional support, etc. Endoscopic closure attempt with devices such as, but not limited to; endo-stitch, clipping, surgical sealants, etc. This attempt may be with or without diversion of the luminal contents by stenting. Radiographic Imaging within 7 days of fistula plug placement (e.g. CT, PET, etc.). Exclusion Criteria Inability to give informed consent. Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. Specific exclusions; a. Evidence of hepatitis B, C, or HIV Investigational drug within thirty (30) days of baseline A resident outside the United States History of clinically significant auto-immunity (i.e. Inflammatory Bowel Disease). Previous allergic reaction to a fistula plug. If obtaining sufficient adipose tissue for manufacturing is not technically feasible Allergic to local anesthetics Pregnant patients or trying to become pregnant or breast feeding. Non-enterocutaneous tracts Fistula output >2000 ml/day Multiple or end fistulas Fistulous tract <2 cm in length Fistulous tract or defect >1 cm in diameter, Fistulas opening into abdominal wall defect. Diseased adjacent bowel, fistula in the radiation field, persistent distal obstruction or malignancy Patients on immunosuppression or chemotherapy Uncontrolled diabetes, i.e. blood sugar more than 200 Sepsis Fistulas arising from a malignant lesion Patients with obstructive malignancies Patients with stage III and/or stage IV cancers. The investigators will exclude patients with stage III or IV cancers, poorly differentiated cancers and patients with less than accepted disease free surgical margins.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William A Faubion, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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Stem Cell Fistula Plug in Post Surgical Leak Fistulas

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