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Suffering from Fecal Incontinence?
For some patients, medical treatments have not allowed for sustained resolution of FI.
Cellf BIO provides a treatment that aims to restore the normal physiological function of
the anorectum.
Innovative Cell-Based Therapy - BioSphincter
The experimental BioSphincter is bioengineered from your own smooth muscle cells
and neural stem cells, retrieved in a biopsy procedure — eliminating any risk of
rejection.
The newly grown autologous sphincter will be implanted in the area of the defective
sphincter and will form a new continuum of the patientʼs own gastrointestinal tract.
Click here to learn more and to see if you’re eligible!
Frequently Asked Questions
1. What is a Clinical Trial?
A clinical trial is a research study conducted in human patients that evaluates an
experimental medical, surgical, or behavioral intervention. This is one of the primary
steps taken to find out new and better treatments — like a drug or device. A clinical trial
assesses the effectiveness and side effects of the new treatment compared to the
standard treatment.
2. Am I eligible to participate?
To assess your eligibility yourself, ask these questions:
● Do I have severe FI? (over a one-year period with four or more FI episodes in a
two-week period).
● Have I failed standard medical treatments?
If answered yes for both questions, contact our study staff and they will reach out with
next steps.
3. What can I expect if I am eligible?
● The duration of the study is three years after implantation at VCU Medical Center
in Richmond, Virginia.
● Compensation will be given to patients that complete the study.
● There are two surgical procedures — two surgical biopsies performed at the
same time and then surgical implantation of the BioSphincter
4. How long will I be in this study?
The participant will receive the BioSphincters in two surgical procedures 6 to 8 weeks
after biopsy. The patient will be followed for a year after implantation. The study will
continue to follow your condition yearly for two more years.
5. What medical records are needed to determine study eligibility?
● Record of Anorectal Manometry
● Colonoscopy within the past five years
● Records from your physician about the types of treatment which have been tried
for fecal incontinence.
Who To Contact
VCU Department of Surgery, Division of Colon and Rectal Surgery
Email: vcusurgerytrials@vcuhealth.org
Phone Number: 1-844-423-5532
Please indicate in the subject line:
“Cellf BIO - FI Study Inquiry”
All interested patients will be screened by the study staff for eligibility.
Diagnostic reports and medical records must be faxed to study staff at 804-827-0670.
For some patients, medical treatments have not allowed for sustained resolution of FI.
Cellf BIO provides a treatment that aims to restore the normal physiological function of
the anorectum.
Innovative Cell-Based Therapy - BioSphincter
The experimental BioSphincter is bioengineered from your own smooth muscle cells
and neural stem cells, retrieved in a biopsy procedure — eliminating any risk of
rejection.
The newly grown autologous sphincter will be implanted in the area of the defective
sphincter and will form a new continuum of the patientʼs own gastrointestinal tract.
Click here to learn more and to see if you’re eligible!
Frequently Asked Questions
1. What is a Clinical Trial?
A clinical trial is a research study conducted in human patients that evaluates an
experimental medical, surgical, or behavioral intervention. This is one of the primary
steps taken to find out new and better treatments — like a drug or device. A clinical trial
assesses the effectiveness and side effects of the new treatment compared to the
standard treatment.
2. Am I eligible to participate?
To assess your eligibility yourself, ask these questions:
● Do I have severe FI? (over a one-year period with four or more FI episodes in a
two-week period).
● Have I failed standard medical treatments?
If answered yes for both questions, contact our study staff and they will reach out with
next steps.
3. What can I expect if I am eligible?
● The duration of the study is three years after implantation at VCU Medical Center
in Richmond, Virginia.
● Compensation will be given to patients that complete the study.
● There are two surgical procedures — two surgical biopsies performed at the
same time and then surgical implantation of the BioSphincter
4. How long will I be in this study?
The participant will receive the BioSphincters in two surgical procedures 6 to 8 weeks
after biopsy. The patient will be followed for a year after implantation. The study will
continue to follow your condition yearly for two more years.
5. What medical records are needed to determine study eligibility?
● Record of Anorectal Manometry
● Colonoscopy within the past five years
● Records from your physician about the types of treatment which have been tried
for fecal incontinence.
Who To Contact
VCU Department of Surgery, Division of Colon and Rectal Surgery
Email: vcusurgerytrials@vcuhealth.org
Phone Number: 1-844-423-5532
Please indicate in the subject line:
“Cellf BIO - FI Study Inquiry”
All interested patients will be screened by the study staff for eligibility.
Diagnostic reports and medical records must be faxed to study staff at 804-827-0670.
