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| Name | Class |
|---|---|
| MIRAE CELL BIO | UNKNOWN |
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This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell group | Experimental | Interstitial cystitis patients who receive submucosal injection of hESC-MSCs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-MC-01 | Drug | Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Any TEAEs reported by patients or assessed by laboratory and image work up | 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 | 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 | 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 | 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 | Twelve months after stem cell injection |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of pain after stem cell injection | Assessed by VAS (Visual Analog Scale) | 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 |
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Inclusion Criteria:
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
Who can understand consent form and willing to participate in the study
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myung-Soo Choo, M.D, Ph.D | Contact | +82230103735 | mschoo@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Myung-Soo Choo, M.D, Ph.D | Professor, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40387787 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 17, 2021 | |
| Reset | Mar 9, 2022 | |
| Release | May 21, 2022 | |
| Reset | Feb 23, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 17, 2021 | Mar 9, 2022 | |||
| May 21, 2022 |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Assessed by PUF questionnaire
| 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 | 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) | 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) | Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection |
| Feb 23, 2023 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |