Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 7:06 AM
Study NCT ID:
NCT04610359
Status:
UNKNOWN
Last Update Posted:
2020-10-30
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-09', 'releaseDate': '2021-12-17'}, {'resetDate': '2023-02-23', 'releaseDate': '2022-05-21'}], 'estimatedResultsFirstSubmitDate': '2021-12-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'One month after stem cell injection', 'description': 'Any TEAEs reported by patients or assessed by laboratory and image work up'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Three months after stem cell injection', 'description': 'Any TEAEs reported by patients or assessed by laboratory and image work up'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Six months after stem cell injection', 'description': 'Any TEAEs reported by patients or assessed by laboratory and image work up'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Nine months after stem cell injection', 'description': 'Any TEAEs reported by patients or assessed by laboratory and image work up'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Twelve months after stem cell injection', 'description': 'Any TEAEs reported by patients or assessed by laboratory and image work up'}], 'secondaryOutcomes': [{'measure': 'Changes of pain after stem cell injection', 'timeFrame': 'Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection', 'description': 'Assessed by VAS (Visual Analog Scale)'}, {'measure': 'Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection', 'timeFrame': 'Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection', 'description': 'Assessed by PUF questionnaire'}, {'measure': "Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection", 'timeFrame': 'Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection', 'description': 'Assessed by ICQ questionnaire'}, {'measure': 'Changes of voiding profiles after stem cell injection', 'timeFrame': 'Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection', 'description': 'Assessed by voiding diary (frequency, nocturia, urgency, urge incontinence and mean voided volume)'}, {'measure': 'Changes of Hunner lesion after stem cell injection', 'timeFrame': 'Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection', 'description': 'Assessed by cystoscopy (number, sized, location)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Cystitis', 'Stem Cell Transplant', 'Mesenchymal Stem Cell']}, 'referencesModule': {'references': [{'pmid': '40387787', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, aged \\>= 20 years\n* Interstitial cystitis symptom duration more than 6 months\n* Presence of Hunner lesions in outpatient cystoscopy (within one months of screening), with size \\< 2cm, number \\<= 2\n* VAS (Visual pain analogue scale) \\>=4 in screening symptom questionnaire\n* Those who are suitable for stem cell transplantation\n\n * normal laboratory findings (hematological, chemical)\n * no history of drug abuse\n * negative HIV, HBV, HCV serology tests\n * No history of malignancies\n * willing to contraception\n * no plan for blood, tissue donation\n* Who can understand consent form and willing to participate in the study\n\nExclusion Criteria:\n\n* 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\n* any active or past history of tuberculosis or systemic infection\n* Anatomical abnormality of lower urinary tract\n* History of following procedures\n\n * stem cell transplantation In past 6 months,\n * transurethral resection/fulguration of Hunner lesion or hydrodistension of bladder\n * intravesical instillation of ialuril\n * hysterectomy, anti-incontinence surgery, transvaginal surgery, pelvic organ prolapse repair, vagina delivery or C/sec\n * any neurological conditions including cerebrovascular disease, multiple sclerosis, spinal cord injury, Parkinson disease\n * indwelling Foley catheter or intermittent catheterization\n * any plans for electrostimulation, neuromodulation, physiotherapy or operation for other organs\n * any history of malignancy\n * history of myocardiac infarction in past 12 months\n * Uncontrolled diabetes (HbAlc \\>= 7.2%) or diabetes requiring insulin injection\n * Uncontrolled hypertension (systolic \\>170mmHg or \\<90mmHg, diastolic \\>100mmHg or \\<50mmHg)\n * Immunodeficiency\n * Positive HBV, HCV, HIV, syphilis\n * pregnant or on breast feeding\n * any history of drug, alcohol abuse. mis-use\n * Any significant signs, symptoms or previous diagnosis of psychological disorder\n * Impossible to follow scheduled visits\n * Currently participating or participated in other clinical studies within past 3 months\n * Allergic to protein products (serum), antibiotics (gentamicin), DMSO (Dimethyl sulfoxide)\n * Any circumstances that is not suitable for participating or continuing clinical study or participants who clinical investigator considers not suitable for participation'}, 'identificationModule': {'nctId': 'NCT04610359', 'briefTitle': 'Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study', 'orgStudyIdInfo': {'id': '2019-1451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem cell group', 'description': 'Interstitial cystitis patients who receive submucosal injection of hESC-MSCs', 'interventionNames': ['Drug: MR-MC-01']}], 'interventions': [{'name': 'MR-MC-01', 'type': 'DRUG', 'description': 'Submucosal injection of 2.0 x 10,000,000/5ml (1mL \\* 5 sites)', 'armGroupLabels': ['Stem cell group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myung-Soo Choo, professor', 'role': 'CONTACT', 'email': 'mschoo@amc.seoul.kr', 'phone': '82-2-3010-3735'}], 'facility': 'Department of Urology, Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Myung-Soo Choo, M.D, Ph.D', 'role': 'CONTACT', 'email': 'mschoo@amc.seoul.kr', 'phone': '+82230103735'}], 'overallOfficials': [{'name': 'Myung-Soo Choo, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'MIRAE CELL BIO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Myung-Soo Choo', 'investigatorAffiliation': 'Asan Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-12-17', 'type': 'RELEASE'}, {'date': '2022-03-09', 'type': 'RESET'}, {'date': '2022-05-21', 'type': 'RELEASE'}, {'date': '2023-02-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Myung-Soo Choo, Professor, Asan Medical Center'}}}}