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Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)

NCT ID: NCT02589119

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-09-30

Brief Summary

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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, ages 18 years and older with cryptoglandular fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore Fistula Plug; fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.

Detailed Description

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The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore\® Bio-A\® Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients (age \> 18 years) with cryptoglandular fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore\® fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. Study visits are Day 1, Week 2, Week 4, Week 8, Week 12, Week 24, Week 52, and Week 104. This is an autologous product derived from the patient and used only for the same patient.

Conditions

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Perianal Fistula Cryptoglandular Perianal Fistula

Keywords

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cryptoglandular perianal fistula cryptoglandular perianal fistulas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MSC-AFP

Single Treatment Group

Group Type OTHER

MSC-AFP

Intervention Type DRUG

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

Interventions

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MSC-AFP

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

Intervention Type DRUG

Other Intervention Names

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mesenchymal stromal cell coated fistula plug

Eligibility Criteria

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Inclusion Criteria

1. Males and females 18-65 years of age.
2. Residents of the United States.
3. Single-tract, transsphincteric anal fistula of cryptoglandular origin. Primary fistulas (no previous surgical treatment) and those who have failed previous surgical repairs
4. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
5. Ability to comply with protocol
6. Competent and able to provide written informed consent

Exclusion Criteria

1. Inability to give informed consent.
2. 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.
3. Specific exclusions; Evidence of hepatitis B, C, or HIV
4. History of cancer including melanoma (with the exception of localized skin cancers)
5. Investigational drug within thirty (30) days of baseline
6. A resident outside the United States
7. Pregnant or breast feeding.
8. History of clinically significant auto-immunity (e.g. Crohn's disease) or any previous example of fat-directed autoimmunity
9. Previous allergic reaction to a perianal fistula plug.
10. If liposuction is not technically feasible
11. Allergic to local anesthetics
12. Pregnant patients or trying to become pregnant.
13. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)
14. Multi-tract, suprasphincteric and extrasphincteric fistula tract extensions
15. Active local infection associated with the fistula
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Eric J. Dozois, M.D.

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric J Dozois, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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

Mayo Clinic Clinical Trials

Other Identifiers

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15-003200

Identifier Type: -

Identifier Source: org_study_id