Interstitial Cystitis, Mesenchymal Stem Cell, Stem Cell Transplant
Conditions
Brief summary
This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
Interventions
DRUGMR-MC-01
Submucosal injection of 2.0 x 10,000,000/5ml (1mL \* 5 sites)
Sponsors
MIRAE CELL BIO
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | One month after stem cell injection | Any TEAEs reported by patients or assessed by laboratory and image work up |
| Incidence of Treatment-Emergent Adverse Events | Three months after stem cell injection | Any TEAEs reported by patients or assessed by laboratory and image work up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection | Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection | Assessed by ICQ questionnaire |
| Changes of pain after stem cell injection | Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection | Assessed by VAS (Visual Analog Scale) |
| Changes of Hunner lesion after stem cell injection | Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection | Assessed by cystoscopy (number, sized, location) |
| Changes of voiding profiles after stem cell injection | Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection | Assessed by voiding diary (frequency, nocturia, urgency, urge incontinence and mean voided volume) |
| Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection | Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection | Assessed by PUF questionnaire |
Countries
South Korea
Contacts
Primary ContactMyung-Soo Choo, M.D, Ph.D
Outcome results
None listed