Fecal incontinence and defecation disorder
Conditions
Interventions
Mesenchymal stem cells are administered into the anal canal.
Sponsors
Miyoshi Norikatsu
ROHTO PHARMACEUTICAL CO.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1st registration: 1)Fecal incontinence patients and defecation disorder patients 2)Patients who meet any of the following (1) to (4) (1)Wexner Score 11 or higher (2)Low Anterior Resection Syndrome (LARS) Score 21 or higher (3)Japanese version of the Faecal Incontinence Quality of Life scale (JFIQL) 2.6 or below (4)Fecal Incontinence Severity Index (FISI) 20 or higher 3)Men and women whose consent acquisition date is more than 18 years old 4)Obtain written consent in person sufficient explanation about this study 2nd registration: 1)Patients for whom specific processed cells have been produced 2)Patients who have given their written consent in person to receive specific processed cells
Exclusion criteria
Exclusion criteria: 1st registration: 1)Patients who have undergone external sphincterotomy 2)Patients with carcinoma or receiving postoperative adjuvant therapy 3)Patients with autoimmune diseases 4)Those who have experienced hypersensitivity or allergic reactions to drugs such as anesthetics used during fat collection and administration specific processed cells, antibiotics that may be used during cell processing, and contrast media used in imaging tests. 5)Persons with confirmed infection (syphilis, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human T-cell leukemia virus, parvovirus B19, mycoplasma infection) 6)Those who have been judged by the physician in charge to be unable to collect the necessary amount of fat for treatment, or unable to do so safely 7)Those who are pregnant 8)Persons with mental illnesses that are judged to affect their ability to obtain consent 9)Drug or alcohol abusers 10) Patients who would like standard treatment, even though it will be more invasive than the treatment in place at the time consent is obtained. 11)Participating in any other clinical trial or within 6 months of having completed a clinical trial 12)Patients who have been judged by the physician in charge to be inappropriate for treatment (participation in research). 2nd registration: 1)Patients who withdrew their consent to participate in this study 1st registration 2)Patients deemed inappropriate by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and number of adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Improvement of Wexner Score 2)Improvement of FISI 3)Improvement of JFIQL 4)Improvement of LARS Score 5)Amount of change in intrarectal pressure (pressure value) 6)Amount of change in the amount of levator ani muscle (volumetry from the anal verge to the lower edge of the fourth sacral vertebra) | — |
Countries
Japan
Contacts
Public ContactHikaru Sato
The University of Osaka Hospital
Outcome results
None listed