Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 8:33 AM
Study NCT ID:
NCT06889857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Intravenous Administration of SHED-CM for ALS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A group of ALS patients receiving the study drug'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All Adverse Events', 'timeFrame': 'Immediately after each administration and up to 4 weeks post-treatment', 'description': 'This measure will check the total number of adverse events (AEs) reported during the study, categorized by CTCAE Ver 5.0 .'}, {'measure': 'Number of Clinically Significant Changes in Laboratory Test Results', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, and at follow-up (Week 16).', 'description': 'This measure will track the number of events where clinically significant abnormalities are detected in laboratory test parameters, including blood count, biochemistry, and coagulation function tests. Changes from baseline to follow-up are evaluated based on predefined clinical thresholds.'}, {'measure': 'Number of Clinically Significant Changes in Vital Signs', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, and at follow-up (Week 16).', 'description': 'This measure will evaluate the number of events where clinically significant changes in vital signs occur. Parameters include systolic blood pressure, diastolic blood pressure, pulse rate, body temperature, and SpO2. Each event will be assessed at two time points: immediately after treatment and after follow-up session, comparing values to baseline.'}, {'measure': 'Safety assessment during the study period: Adverse events - Self- and other findings', 'timeFrame': 'Immediately after each administration and up to 4 weeks post-treatment', 'description': 'Medical examination, subjective findings, Other findings'}], 'secondaryOutcomes': [{'measure': 'Efficacy assessment: ALSFRS-R', 'timeFrame': 'Change from baseline ALSFRS-R at follow-up session', 'description': 'The revised ALS Functional Rating Scale in ALS Patients. This scale is scored from 0 to 48, the higher the score the better.'}, {'measure': 'Efficacy assessment: %FVC', 'timeFrame': 'Change from baseline %FVC at follow-up session', 'description': '% forced vital capacity in ALS Patients'}, {'measure': 'Efficacy assessment: grip strength', 'timeFrame': 'Change from baseline grip strength at follow-up session', 'description': 'grip strength in ALS Patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALS - Amyotrophic Lateral Sclerosis', 'Stem Cells', 'Conditioned Medium', 'Therapy', 'Safety', 'Regenerative Medicine'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '35532908', 'type': 'BACKGROUND', 'citation': 'Oki R, Izumi Y, Fujita K, Miyamoto R, Nodera H, Sato Y, Sakaguchi S, Nokihara H, Kanai K, Tsunemi T, Hattori N, Hatanaka Y, Sonoo M, Atsuta N, Sobue G, Shimizu T, Shibuya K, Ikeda K, Kano O, Nishinaka K, Kojima Y, Oda M, Komai K, Kikuchi H, Kohara N, Urushitani M, Nakayama Y, Ito H, Nagai M, Nishiyama K, Kuzume D, Shimohama S, Shimohata T, Abe K, Ishihara T, Onodera O, Isose S, Araki N, Morita M, Noda K, Toda T, Maruyama H, Furuya H, Teramukai S, Kagimura T, Noma K, Yanagawa H, Kuwabara S, Kaji R; Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS (JETALS) Collaborators. Efficacy and Safety of Ultrahigh-Dose Methylcobalamin in Early-Stage Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2022 Jun 1;79(6):575-583. doi: 10.1001/jamaneurol.2022.0901.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/35532908/', 'label': 'We referenced this paper because of the Phase III trial in ALS.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media (SHED-CM) in patients with Amyotrophic Lateral Sclerosis (ALS), using the Japanese version of the revised ALS Functional Rating Scale (ALSFRS-R) as an indicator.', 'detailedDescription': "The main objective of this study is to evaluate the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media in patients with Amyotrophic Lateral Sclerosis (ALS), Particular focus will be placed on improving neurological function, slowing the rate of symptom progression, and improving the patient's quality of life.\n\nWhat are the advantages of this therapy over standard therapy? and for which patients it is most effective ?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who meet the following inclusion criteria (1) to (6) at the time of Informed consent\n\n1. Patients who have provided written informed consent to participate in the study.\n2. Patients who are at least 20 years of age at the time of obtaining informed consent.\n3. Patients diagnosed with isolated or familial ALS and diagnosed as definite, the probable, or the probable laboratory-supported by updated Awaji criteria.\n4. Patients with severity 1 or 2 on ALS severity criteria.\n5. Outpatients.\n6. Patients residing in Japan who can communicate in Japanese.\n\nExclusion Criteria:\n\nPatients who do not meet any of the exclusion criteria (1) to (15) at the time of Informed consent\n\n1. Patients with a tracheostomy\n2. Patients with a history of non-invasive respiratory support\n3. Patients with a percent FVC of 60 or less\n4. Patients with chronic obstructive pulmonary disease (COPD)\n5. Patients newly treated with edaravone or riluzole (oral) within 4 weeks prior to Informed consent\n6. Patients receiving HAL medical leg type treatment\n7. Patients receiving intravenous edaravone\n8. Patients with cognitive impairment\n9. Pregnant women or patients who may be pregnant\n10. Patients with serious respiratory, cardiovascular, hepatic, or renal disease\n11. Patients with malignant tumors\n12. Patients with uncontrolled infection\n13. Patients who have participated in other clinical trials within 12 weeks prior to obtaining consent\n14. Patients with a history of drug allergy or severe allergic disease (e.g., anaphylactic shock) or concomitant history\n15. Patients who are deemed inappropriate to participate in the study by the principal investigator or research coordinator.'}, 'identificationModule': {'nctId': 'NCT06889857', 'acronym': 'SCA202401', 'briefTitle': 'Safety and Efficacy of Intravenous Administration of SHED-CM for ALS', 'organization': {'class': 'OTHER', 'fullName': 'Hitonowa Medical'}, 'officialTitle': 'Safety and Efficacy of Intravenous Administration of SHED-CM for ALS', 'orgStudyIdInfo': {'id': 'SHED-CM-ALS-202401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receiving the study drug', 'description': 'The study drug will be administered intravenously at 120 ml once a week for 12 week.', 'interventionNames': ['Biological: The study drug is SHED-CM manufactured by U-Factor']}], 'interventions': [{'name': 'The study drug is SHED-CM manufactured by U-Factor', 'type': 'BIOLOGICAL', 'description': 'This study will involve informed consent, a 12-week observation period, a 12-week study drug administration period, and a 4-week follow-up period.', 'armGroupLabels': ['Receiving the study drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102-0085', 'city': 'Chiyoda City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Hitonowa Medical', 'geoPoint': {'lat': 35.68449, 'lon': 139.75056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hitonowa Medical', 'class': 'OTHER'}, 'collaborators': [{'name': 'U-Factor Co.,Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}