None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Phase 1 (~28D)
Open, two dose groups, Submucosal injection, Sing dose
-MR-MC-01: low dose (1.0 x 10^8)
-MR-MC-01: high dose (2.0 x 10^8)
Phase 2a (~6M)
Double blind
Sponsors
Mirae Cell Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults over the age of 19 2) Subjects who consented to use contraception during the clinical trial period 3) More than 6 months have passed since symptoms clinically suspected of having an underactive bladder (low urinary rate (medicated urine), need attention, giving strength to look lustrous), When the residual urine test result measured at screening is 200 cc or more and the following findings are shown -Male: BCI<100, BOOI<20**, BVE<90% -Female: PdetQmax=20, Qmax<15, BVE<90% ** BCI = PdetQmax + 5Qmax BOOI=PdetQmax – 2Qmax 4) When drug treatment is difficult due to excessive response to drug treatment for underactive bladder 5) Subjects who can create a voiding diary provided in this clinical trial 6) Subjects who can urinate as indicated without completely relying on intermittent urination because intermittent urination (Clean Intermittent Catheterization, CIC) must be resumed from 1 month prior to screening if self-urination is performed. 7) Subjects who have agreed in writing to participate after listening to the explanation of this clinical trial
Exclusion criteria
Exclusion criteria: 1) This product is recommended for use in tanning products, biological products (gentamicin), DMSO (Dimethyl sulfoxide), etc. 2)Before screening?Health care practitioner 3) The person who will write the text, the person who will love the picture 4) Those who have died after 5 years of screening 5) Inflammation of urinary tract infection (urinary tract infection) 6) Healing effect with low blood pressure, low blood pressure, low blood pressure, corticosteroid disease 7)Subjects who have the following conditions that may cause underactive bladder or potentially affect the outcome of treatment: - Pre-existing neurological disease such as cerebrovascular disease, disc prolapse, spinal cord injury, multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome (GBS), vulva/hypothalamus/pelvis at screening - Surgery or procedure for bladder, urethral, ??benign prostatic obstruction, or pelvic organ prolapse within 6 months prior to screening - If you have a history of pelvic radiotherapy 8) Subjects who underwent intravesical electrical stimulation within 3 months before screening 9) Subjects who participated in a voiding training program within 6 weeks before screening 10) If diagnosed with clinically meaningful pelvic organ prolapse at screening 11) Diagnosed with intestinal obstruction or bladder outlet obstruction at the time of screening 12) If urine is contraindicated at screening or during participation in this clinical trial 13) Screening clinical laboratory test results, if: -ALT > 3x ULN -AST > 3x ULN - Serum Creatinine > 2x ULN 14) If you have or are being treated for an active infectious disease (tuberculosis, target herpes, etc.), or if you have the applicable past or therapeutic ability within 6 months prior to screening 15) Subjects diagnosed with hyperthyroidism within 6 months before screening 16) Subjects diagnosed with deep vein or myocardial infarction within 6 months before screening 17) Uncontrolled hypertension (resting systolic blood pressure >170 mmHg or diastolic blood pressure >90 mmHg) 18) When the investigator determines that it is difficult to participate in this clinical trial due to anatomical abnormalities in the lower urinary tract 19) If electrostimulation/neuromodulation therapy, acupuncture, physical therapy, or other organ surgery is scheduled during the study period 20) Subjects confirmed to be positive for HIV or syphilis at screening 21) If you are pregnant or breastfeeding 22) History of alcohol abuse, drug misuse, or other clinically significant psychiatric diagnosis, or any signs or symptoms associated therewith 23) When it is judged that the degree of adaptability to the implementation of this clinical trial plan is low 24) Participated in other clinical trials within 3 months prior to screening or currently participating in other clinical trials 25) Subjects who are judged by the investigator to be ineligible for this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event (CTCAE Version 5.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Free Uroflowmetry/Bladder scan | — |
Countries
Korea, Republic of
Contacts
Public ContactSeol a Jung
Asan Medical Center
Outcome results
None listed