Fat Grafting Technique for Fecal Incontinence

The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented
autologous adipose tissue (Lipogems®) in female patients with fecal incontinence. Our
hypothesis is that placing approximately up to 90 cc of Lipogems® will yield an effective
increase in surviving material (over normal fat injection) due to the refinement of the
process and result in decreased fecal incontinence over the long term.

Human Adipose Tissue (Fat) possesses regenerative properties in its stromal vascular fraction
(SVF). SVF contains nests of pericytes and human MSC mesenchymal stem cells). MSCs are
multipotent cells (also called stromal multipotent cells), that possess the ability to
differentiate into various tissues, such as bone, tendon, articular cartilage, ligaments,
muscle, and fat. Upon fragmentation of adipose tissue using Lipogems®, viable elements are
preserved with pericyte identity within an intact stromal vascular niche. It is hypothesized
that upon trauma or disruption of this adipose tissue, the regenerative cells within the
intact perivascular niche interact via micro vesicles with the microenvironment at the
transplant site to promote angiogenesis, neuronal sprouting and fibroblast production thereby
stimulating increased vasculature (circulation, nerve regeneration, muscle growth and tone in
the urethral sphincter and in the urethral muscles). If these changes are observed, long
lasting regenerative changes occur and should be long lasting versus the shorter live effects
of the bulking effect by undisrupted fat tissue.

This is a pilot study of 10 subjects will be treated with local injections of Lipogems® and
followed for up to two years. Subjects will receive a full history and examination by a
single colorectal surgeon. A clear history of their incontinence frequency, Wexner
Incontinence Score, Fecal Incontinence Quality of Life Scale, surgical history, and
childbirth history will be collected for all registered patients in order to categorize the
study participant according to incontinence-type.

All patients will undergo anal physiology testing and endoanal ultrasound. Pre and post
measurements will be recorded and compared for objective evaluation. Patients will be
evaluated subjectively with the Wexner incontinence Score and Fecal Incontinence Quality of
Life Scale.

Patients will have the opportunity to undergo adipose tissue harvesting and targeted local
Injection under ultrasound guidance in muscle defects in the intersphincteric space, all
around the remaining portions of the external anal sphincter, and along the course of the
pudendal nerves bilaterally. This will be done in the procedure room or operating room with
IV sedation and local anesthesia. This will all occur in the same setting on the same day.

Inclusion Criteria:

1. Age: >18 < 75 years

2. Sex: females

3. Affected by fecal incontinence (moderate to severe) independently from the etiology
and previous treatments

4. No restrictions to follow-up for 24 months after treatment

5. Willing and able to provide informed consent

Exclusion Criteria:

1. Present diagnosis of cancer (not in remission)

2. Patients with uncorrected rectal prolapse

3. Overflow incontinence

4. Patients with neurogenic bowel or spinal cord injuries

5. Any patients unable to give informed consent, including members of vulnerable
populations

6. Patients with concomitant pelvic floor disorders, like paradoxical puborectalis
contraction or pelvic floor dysfunction

7. Chronic diarrhea

8. Patients with chronic steroid use

9. Patients 17 and under

10. Anal Sepsis (abscess and/or fistula)

11. Inability to undergo the intended diagnostic tests and follow-up

12. Pregnancy

13. Diagnosis of Diabetes Mellitus 1 and 2