Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06752720
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2024-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of HUNS001-01 administration', 'timeFrame': 'one year', 'description': 'The frequency of the improvement in mRS of disability by 1 or more from baseline'}], 'secondaryOutcomes': [{'measure': 'Safety of HUNS001-01 administration', 'timeFrame': 'one year', 'description': 'frequency of Adverse Event'}, {'measure': 'Change in NIHSS examination', 'timeFrame': 'one year', 'description': 'Mean improvement of NIHSS (0-42, higher score means worse outcome)'}, {'measure': 'Change in FIM examination', 'timeFrame': 'one year', 'description': 'Mean improvement of FIM (18-126, higher score means better outcome)'}, {'measure': 'Change in Fugl-Myer examination', 'timeFrame': 'one year', 'description': 'Mean improvement of Fugl-Myer (0-226, higher score means better outcome)'}, {'measure': 'Change in Barthal index examination', 'timeFrame': 'one year', 'description': 'Mean improvement of Barthal index (0-100, higher score means better outcome)'}, {'measure': 'Change in FDG-PET examination', 'timeFrame': 'one year', 'description': 'Mean improvement of FDG-PET set for ipsilateral motor cortex'}, {'measure': 'Change in IMZ-SPECT examination', 'timeFrame': 'one year', 'description': 'Mean improvement of IMZ-SPECT set for ipsilateral motor cortex'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stem cell therapy', 'mesenchymal stem cell', 'ischemic stroke', 'chronic'], 'conditions': ['Stroke', 'Stroke, Ischemic', 'Stroke; Sequelae']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are:\n\nCan HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention?\n\nParticipants will receive the below interventions.\n\n* Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging)\n* Harvest of platelet concentrates (PC)\n* Harvest of bone marrows (BM)\n* Receive intracerebral transplantation surgery of HUNS001-01\n* Post-operative rehabilitation\n* Follow-up studies (until 1 year or termination of the trial)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Age between 20 and 70 years\n2. Clinical diagnosis of ischemic stroke between 6 months and 5 years ago\n3. Ischemic area in the territory of unilateral interanal cerebral artery\n4. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV\n5. Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging\n6. No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)\n7. Subjects who can give informed consent by its self\n\nExclusion criteria\n\n1. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"\n2. Anaemia (Hg \\< 10·0 g/dL)\n3. Thrombocytopaenia (platelet count \\< 100,000/mm3)\n4. Severe heart disease (ischaemic heart disease, heart failure)\n5. Severe Systemic organ failure ALT \\<3·0× upper limit of normal Total bilirubin \\< 1·5× upper limit of normal Serum creatinine \\< 1·5× upper limit of normal\n6. History of malignancy\n7. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19\n8. Pregnant or lactating or expecting to become pregnant during the study\n9. Known serious allergy to any agents used in the study\n10. Contraindication for magnetic resonance imaging\n11. History of seizure within 2 years\n12. Subject\'s body weight less than 45 kg for male and 40kg for female "13. Participating in another clinical trial within 90 days, or planning to participate in another clinical trial in the future"\n\n14\\. Any condition that in the judgement of the investigator would place the patient at undue risk'}, 'identificationModule': {'nctId': 'NCT06752720', 'acronym': 'RAINBOW-2a', 'briefTitle': 'Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hokkaido University Hospital'}, 'officialTitle': 'Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial', 'orgStudyIdInfo': {'id': 'R6-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem cell transplantation', 'description': 'Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10\\^7 MSC cells)', 'interventionNames': ['Drug: Stem cell Transplantation']}], 'interventions': [{'name': 'Stem cell Transplantation', 'type': 'DRUG', 'description': 'Manufactured autologous mescenchymal stem cell (HUNS001-01) in our cell processing center will be injected into the brain, totally 4 x 10\\^7 cells, in 2 brain sites.', 'armGroupLabels': ['Stem cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0608638', 'city': 'Sapporo', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kota Kurisu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'kkurisu0912@gmail.com', 'phone': '81-11-706-1061', 'phoneExt': '5987'}], 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}], 'centralContacts': [{'name': 'Kota Kurisu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'kkurisu0912@gmail.com', 'phone': '+81-11-706-1161', 'phoneExt': '5987'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hokkaido University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RAINBOW Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}