Interstitial CystitisPhase 1NCT04610359
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis
A Phase 1 study testing MR-MC-01 in people with Interstitial Cystitis and Stem Cell Transplant, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Interstitial Cystitis, Stem Cell Transplant, Mesenchymal Stem Cell
- What is being tested?
- MR-MC-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Oct 2020to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Urology, Asan Medical Center
Seoul, 138-736
Myung-Soo Choo, professor, 82-2-3010-3735, mschoo@amc.seoul.kr
About this study
Official title: Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study
This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
- Being tested
- MR-MC-01
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-MC-01Drug
Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites)
| Study group | Role | What they receive |
|---|---|---|
| Stem cell group | Experimental | Interstitial cystitis patients who receive submucosal injection of hESC-MSCs Receives: Drug: MR-MC-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Any TEAEs reported by patients or assessed by laboratory and image work up
Measured: One month after stem cell injection
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Measured: Three months after stem cell injection
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Measured: Six months after stem cell injection
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Measured: Nine months after stem cell injection
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Measured: Twelve months after stem cell injection
Secondary outcomes (5)
Changes of pain after stem cell injection
Assessed by VAS (Visual Analog Scale)
Measured: Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection
Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection
Assessed by PUF questionnaire
Measured: Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection
Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection
Assessed by ICQ questionnaire
Measured: Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection
Changes of voiding profiles after stem cell injection
Assessed by voiding diary (frequency, nocturia, urgency, urge incontinence and mean voided volume)
Measured: Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection
Changes of Hunner lesion after stem cell injection
Assessed by cystoscopy (number, sized, location)
Measured: Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start20 Oct 2020
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- MIRAE CELL BIO
- Responsible party
- Principal investigator, Myung-Soo Choo, Asan Medical Center
- Investigators
- Myung-Soo Choo, M.D, Ph.D, Principal investigator, Professor, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610359
- Sponsor's protocol ID
- 2019-1451
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40387787
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study
- ClinicalTrials.gov ID
- NCT04610359
- Acronym / sponsor ID
- 2019-1451
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- MIRAE CELL BIO
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell group | Experimental | Drug: MR-MC-01Interstitial cystitis patients who receive submucosal injection of hESC-MSCs |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-MC-01Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites) | Drug | Stem cell group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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
Time frame: Three months after stem cell injection
Any TEAEs reported by patients or assessed by laboratory and image work up
Incidence of Treatment-Emergent Adverse Events
Time frame: Six months after stem cell injection
Any TEAEs reported by patients or assessed by laboratory and image work up
Incidence of Treatment-Emergent Adverse Events
Time frame: Nine months after stem cell injection
Any TEAEs reported by patients or assessed by laboratory and image work up
Incidence of Treatment-Emergent Adverse Events
Time frame: Twelve months after stem cell injection
Any TEAEs reported by patients or assessed by laboratory and image work up
5 secondary outcomes
Changes of pain after stem cell injection
Time frame: Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection
Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection
Time frame: Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection
Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection
Time frame: Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection
Changes of voiding profiles after stem cell injection
Time frame: Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection
Changes of Hunner lesion after stem cell injection
Time frame: Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Derived from this study: PubMed 40387787Kyung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung-Soo Choo, M.D, Ph.D principal investigator
Professor, Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MR-MC-01 in people with Interstitial Cystitis and Stem Cell Transplant, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Soo Choo, M.D, Ph.D (+82230103735, mschoo@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: One month after stem cell injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.