None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Phase 1
Open, two dose groups
- MR-MC-01: low dose
- MR-MC-01: high dose
Phase 2a
Double blind, Parallel
-MR-MC-01 group (set as MTD confirmed in Phase 1)
-placebo g
Sponsors
Mirae Cell Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female over the age of 19 2) Women of childbearing potential who agree to use a medically accepted method of contraception during the clinical trial period 3) Those who have had the following symptoms and pain (but not limited to this) due to interstitial cystitis for more than 6 weeks 4) Those with Hunner lesions confirmed by cystoscopy within 1 month before screening 5) Patients who do not respond to the administration of sodium pentosan polysulfate as a treatment for this indication or cannot apply sodium pentosan polysulfate treatment according to the judgment of the investigator 6) If the pain evaluation due to interstitial cystitis at screening and baseline visit is 4 or higher on the 10-point Visual Analogue Scale (VAS) 7) If the total score of the O'Leary-Sant Interstitial Cystitis Questionnaire (ICQ) at screening is 12 or more (up to baseline in case of phase 2a) 8) When the total PUF questionnaire score (up to baseline in case of phase 2a) is 13 or more at screening 9) Those who can urinate on their own and move for urination 10) A person who can write a diary, such as a urination diary, a rescue drug diary, etc. to be provided in this clinical trial 11) Those who have listened to the explanation of this clinical trial and consented to voluntary participation in writing
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to protein products (serum), antibiotics (gentamicin), DMSO (dimethyl sulfoxide) necessary for the manufacture of this clinical trial drug 2) Persons with hypersensitivity to pregabalin ingredients 3) Those who have treatment history using stem cells before screening 4) Diagnosed with recurrent urinary tract infection (2 or more recurrences in 6 months prior to screening or 3 or more recurrences in 1 year prior), or currently diagnosed with urinary tract infection, acute or chronic prostatitis, chronic pelvic pain syndrome, enlarged prostate, vaginitis, urethritis If you have a disease that shows symptoms similar to this indication, such as 5) If you are suffering from an active infectious disease (tuberculosis, herpes zoster, etc.) 6) In case the investigator judges that it will be difficult to participate in this clinical trial due to anatomical abnormalities of the lower urinary tract 7) In case of taking tricyclic antidepressants (eg, Pentosan polysulfate sodium, Amitriptyline HCl, etc.) or gabapentinoid drugs (eg, Gabapentin, Pregabalin) for this indication within 2 weeks before screening 8) In relation to this indication, a person with the following past history ? In the case of receiving a procedure or therapy that may affect the efficacy evaluation in relation to this indication listed in ‘6.6.1-?’ of the clinical trial protocol within 6 months before screening ? Those with a history of urethral dilatation or urethrectomy within 3 months prior to screening 9) Those who have had a history of hysterectomy, urinary incontinence surgery, hard surgery, pelvic organ prolapse surgery, vaginal delivery or cesarean section within 6 months before screening 10) Persons suffering from neurological diseases such as stroke, multiple sclerosis, spinal cord injury or Parkinson's disease 11) If an indwelling catheter is being used at the time of screening, or if intermittent self-catheterization is performed repeatedly or habitually 12) If electrical stimulation/neuromodulation therapy, acupuncture, physical therapy, or other organ surgery is scheduled during this clinical trial 13) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 14) If there is a history of myocardial infarction within 1 year before screening 15) If you have uncontrolled diabetes (HbA1c = 9%) or are taking insulin 16) Have uncontrolled hypertension (SBP > 170 mmHg or DBP > 100 mmHg) or hypotension (SBP < 90 mmHg or DBP < 50 mmHg) 17) If you have been diagnosed with immunodeficiency 18) If you are receiving intermittent or continuous low-dose treatment with corticosteroids, corticosteroids, or immunosuppressants 19) When the results of clinical laboratory tests confirmed during screening exceed the results below ?ALT exceeds 3 times the upper limit of normal organ ?AST exceeds 3 times the upper limit of normal organ ? Serum Creatinine exceeds twice the upper limit of normal organ 20) Persons judged by the investigator to have a history of drug abuse or drug abuse at the time of screening 21) Those who are confirmed as positive for HIV or syphilis 22) Those with a history of malignancy but less than 5 years in complete remission 23) Those who plan or plan to donate blood and tissue (blood donation and organ donation, etc.) after participating in this clinical trial 24) If you are pregnant or lactating 25) If there is a history of clinically significant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event (CTCAE Version 5.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom improvement through questionnaire evaluation (ICQ, ICSI, ICPI, VAS, GRA), Only in phase 2a | — |
Countries
Korea, Republic of
Contacts
Public ContactChang SuK Lee
Asan Medical Center
Outcome results
None listed