Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04610359
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT04610359
Study Brief:
Protocol Section:
NCT04610359