Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis

Inclusion Criteria:

• Female, aged >= 20 years
• Interstitial cystitis symptom duration more than 6 months
• Presence of Hunner lesions in outpatient cystoscopy (within one months of screening),with size < 2cm, number <= 2
• VAS (Visual pain analogue scale) >=4 in screening symptom questionnaire
• Those who are suitable for stem cell transplantation
• normal laboratory findings (hematological, chemical)
• no history of drug abuse
• negative HIV, HBV, HCV serology tests
• No history of malignancies
• willing to contraception
• no plan for blood, tissue donation
• Who can understand consent form and willing to participate in the study

Exclusion Criteria:

• recurrent urinary tract infection ( more than twice per past six months or more thanthree times per past one year) or active urinary tract infection
• any active or past history of tuberculosis or systemic infection
• Anatomical abnormality of lower urinary tract
• History of following procedures
• stem cell transplantation In past 6 months,
• transurethral resection/fulguration of Hunner lesion or hydrodistension ofbladder
• intravesical instillation of ialuril
• hysterectomy, anti-incontinence surgery, transvaginal surgery, pelvic organprolapse repair, vagina delivery or C/sec
• any neurological conditions including cerebrovascular disease, multiplesclerosis, spinal cord injury, Parkinson disease
• indwelling Foley catheter or intermittent catheterization
• any plans for electrostimulation, neuromodulation, physiotherapy or operation forother organs
• any history of malignancy
• history of myocardiac infarction in past 12 months
• Uncontrolled diabetes (HbAlc >= 7.2%) or diabetes requiring insulin injection
• Uncontrolled hypertension (systolic >170mmHg or <90mmHg, diastolic >100mmHg or <50mmHg)
• Immunodeficiency
• Positive HBV, HCV, HIV, syphilis
• pregnant or on breast feeding
• any history of drug, alcohol abuse. mis-use
• Any significant signs, symptoms or previous diagnosis of psychological disorder
• Impossible to follow scheduled visits
• Currently participating or participated in other clinical studies within past 3months
• Allergic to protein products (serum), antibiotics (gentamicin), DMSO (Dimethylsulfoxide)
• Any circumstances that is not suitable for participating or continuing clinicalstudy or participants who clinical investigator considers not suitable forparticipation