This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Submucosal injection of 2.0 x 10,000,000/5ml (1mL \* 5 sites)
Department of Urology, Asan Medical Center
Seoul, South Korea
RECRUITINGIncidence of Treatment-Emergent Adverse Events (TEAEs)
Any TEAEs reported by patients or assessed by laboratory and image work up
Time frame: One month after stem cell injection
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Time frame: Three months after stem cell injection
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Time frame: Six months after stem cell injection
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Time frame: Nine months after stem cell injection
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Time frame: Twelve months after stem cell injection
Changes of pain after stem cell injection
Assessed by VAS (Visual Analog Scale)
Time frame: Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection
Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection
Assessed by PUF questionnaire
Time frame: Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection
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Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection
Assessed by ICQ questionnaire
Time frame: Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection
Changes of voiding profiles after stem cell injection
Assessed by voiding diary (frequency, nocturia, urgency, urge incontinence and mean voided volume)
Time frame: Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection
Changes of Hunner lesion after stem cell injection
Assessed by cystoscopy (number, sized, location)
Time frame: Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection