Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05018793
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2021-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (adverse events)', 'timeFrame': 'Four year follow-up', 'description': 'Clinical monitoring of possible adverse events or complications'}], 'secondaryOutcomes': [{'measure': 'Efficacy: American Spinal Injury Association Impairment Scale (ASIA)', 'timeFrame': 'Four year follow-up', 'description': 'It will be completed for each follow up point'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal cord injury', 'SCI', 'stem cell treatment'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '31785831', 'type': 'BACKGROUND', 'citation': 'Bydon M, Dietz AB, Goncalves S, Moinuddin FM, Alvi MA, Goyal A, Yolcu Y, Hunt CL, Garlanger KL, Del Fabro AS, Reeves RK, Terzic A, Windebank AJ, Qu W. CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury. Mayo Clin Proc. 2020 Feb;95(2):406-414. doi: 10.1016/j.mayocp.2019.10.008. Epub 2019 Nov 27.'}, {'pmid': '26208177', 'type': 'BACKGROUND', 'citation': 'Hur JW, Cho TH, Park DH, Lee JB, Park JY, Chung YG. Intrathecal transplantation of autologous adipose-derived mesenchymal stem cells for treating spinal cord injury: A human trial. J Spinal Cord Med. 2016 Nov;39(6):655-664. doi: 10.1179/2045772315Y.0000000048. Epub 2015 Jul 24.'}, {'pmid': '27815685', 'type': 'BACKGROUND', 'citation': 'Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This trial will study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cells for the treatment of spinal cord injury', 'detailedDescription': 'Studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (SCI). This patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cell for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Spinal Cord Injury\n* Understanding and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Anticoagulation medicine use\n* Clinically significant Abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.\n* Previous organ transplant\n* Hypersensitivity to sulfur\n* Continued drug abuse\n* Pre-menopausal women not using contraception"}, 'identificationModule': {'nctId': 'NCT05018793', 'briefTitle': 'Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for SCI', 'organization': {'class': 'OTHER', 'fullName': 'The Foundation for Orthopaedics and Regenerative Medicine'}, 'officialTitle': 'Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'SC-8-GR-10-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Single intrathecal injection of 100 million cells', 'interventionNames': ['Biological: autologous adipose derived mesenchymal stem cells', 'Biological: AlloRx']}], 'interventions': [{'name': 'autologous adipose derived mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'cultured autologous adult adipose derived mesenchymal stem cells', 'armGroupLabels': ['Treatment Group']}, {'name': 'AlloRx', 'type': 'BIOLOGICAL', 'description': 'Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal injection for', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': "St John's", 'status': 'RECRUITING', 'country': 'Antigua and Barbuda', 'contacts': [{'name': 'Chadwick C Prodromos, MD', 'role': 'CONTACT', 'email': 'care@thepsci.net', 'phone': '847-699-6810'}], 'facility': 'Medical Surgical Associates Center', 'geoPoint': {'lat': 17.12096, 'lon': -61.84329}}, {'zip': '16675', 'city': 'Glyfada', 'state': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Chadwick C Prodromos, MD', 'role': 'CONTACT', 'email': 'care@thepsci.com', 'phone': '8476996810'}, {'name': 'Chadwick Prodromos, MD', 'role': 'CONTACT'}], 'facility': 'Athens Beverly Hills Medical Group', 'geoPoint': {'lat': 37.86289, 'lon': 23.75802}}], 'overallOfficials': [{'name': 'Chadwick Prodromos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Foundation for Orthopaedics and Regenerative Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Foundation for Orthopaedics and Regenerative Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}