A single-center, phase 1/2a clinical trial to evaluate the safety, maximum tolerated dose, and exploratory efficacy of MR-MC-01 treatment in patients with underactive bladder
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0009028
- Lead Sponsor
- Mirae Cell Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 33
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event (CTCAE Version 5.0)
- Secondary Outcome Measures
Name Time Method Free Uroflowmetry/Bladder scan