Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-02 @ 10:12 AM
Study NCT ID:
NCT07137559
Status:
AVAILABLE
Last Update Posted:
2025-08-22
First Post:
2025-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-14', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['CELZ-201-DDT', 'Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells', 'Mesenchymal Stromal Cells (MSC)', 'Chronic Lower Back Pain', 'Degenerative Disc Disease (DDD)', 'Lumbar Degeneration', 'Chronic Pain', 'Expanded Access', 'Single Patient IND', 'Emergency Use IND', 'Non-Emergency Use IND', 'Compassionate Use', 'Regenerative Medicine', 'Stem Cell Therapy'], 'conditions': ['Chronic Back Pain', 'Degenerative Disc Disease Lumbar']}, 'descriptionModule': {'briefSummary': 'CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.', 'detailedDescription': 'Expanded Access to CELZ-201-DDT (Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells) is available for individual patients with serious or life-threatening chronic lower back pain due to degenerative disc disease (DDD) who have no comparable or satisfactory alternative therapy options.\n\nRequests will be considered on a case-by-case basis under a single-patient IND in coordination with the U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB).\n\nFor non-emergency requests, the treating physician must submit FDA Form 3926 and obtain FDA authorization before initiating treatment.\n\nFor emergency use, treatment may begin without prior FDA authorization if criteria for emergency use are met; the physician must notify the FDA within 5 working days after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of chronic lower back pain due to degenerative disc disease.\n* No comparable or satisfactory alternative therapy available. Unable to participate in the ongoing CELZ-201-DDT clinical trial. Informed consent provided.\n\nExclusion Criteria:\n\n* Any medical condition that poses an unacceptable risk or would interfere with treatment safety or evaluation.\n* Known hypersensitivity to any component of the investigational product.\n\nHow to Request Access:\n\n* Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.\n* Complete and submit FDA Form 3926 to the appropriate FDA review division.\n* Obtain IRB review (may be expedited or post-treatment for emergency use). Coordinate drug shipment and treatment schedule.'}, 'identificationModule': {'nctId': 'NCT07137559', 'acronym': 'ADAPT', 'briefTitle': 'CELZ-201-DDT for the Treatment of Chronic Lower Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Creative Medical Technology Holdings Inc'}, 'officialTitle': 'Expanded Access Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain', 'orgStudyIdInfo': {'id': 'ADAPT Expanded Access'}, 'secondaryIdInfos': [{'id': 'NCT 06053242', 'type': 'OTHER', 'domain': 'clinicaltrials.gov'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'CELZ-201-DDT', 'type': 'DRUG', 'description': 'CELZ-201-DDT is administered via intramuscular injection.\n\nDosing, administration, and follow-up will be determined by the treating physician in accordance with the EA authorization and medical judgment. Safety monitoring will be performed during and after treatment, and all serious adverse events will be reported to the FDA and IRB per applicable regulations.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Creative Medical Technology', 'role': 'CONTACT', 'email': 'expandedaccess@creativemedicaltechnology.com', 'phone': '(702) 588-1890'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creative Medical Technology Holdings Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}