Title
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study
Phase
Phase 1Lead Sponsor
University of UlsanStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Interstitial Cystitis Stem Cell Transplant Mesenchymal Stem CellIntervention/Treatment
MR-MC-01Study Participants
3This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites)
Interstitial cystitis patients who receive submucosal injection of hESC-MSCs
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 than three 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 of bladder intravesical instillation of ialuril hysterectomy, anti-incontinence surgery, transvaginal surgery, pelvic organ prolapse repair, vagina delivery or C/sec any neurological conditions including cerebrovascular disease, multiple sclerosis, spinal cord injury, Parkinson disease indwelling Foley catheter or intermittent catheterization any plans for electrostimulation, neuromodulation, physiotherapy or operation for other 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 3 months Allergic to protein products (serum), antibiotics (gentamicin), DMSO (Dimethyl sulfoxide) Any circumstances that is not suitable for participating or continuing clinical study or participants who clinical investigator considers not suitable for participation