Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis
NCT ID: NCT04610359
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
3 participants
INTERVENTIONAL
2020-10-20
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stem cell group
Interstitial cystitis patients who receive submucosal injection of hESC-MSCs
MR-MC-01
Submucosal injection of 2.0 x 10,000,000/5ml (1mL \* 5 sites)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MR-MC-01
Submucosal injection of 2.0 x 10,000,000/5ml (1mL \* 5 sites)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MIRAE CELL BIO
UNKNOWN
Asan Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Myung-Soo Choo
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Myung-Soo Choo, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Professor, Asan Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Urology, Asan Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Myung-Soo Choo, professor
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Kyung YS, Hong KS, Chung HM, Hyun Shin J, Choo MS, Kim EY, Shin JM, Kang AR, Seo JW, Park J, Park SP. A single-center, phase 1/2a trial of hESC-derived mesenchymal stem cells (MR-MC-01) for safety and efficacy in interstitial cystitis patients. Stem Cells Transl Med. 2025 May 19;14(5):szaf018. doi: 10.1093/stcltm/szaf018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-1451
Identifier Type: -
Identifier Source: org_study_id