Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00919958
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2009-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-17', 'studyFirstSubmitDate': '2009-06-10', 'studyFirstSubmitQcDate': '2009-06-11', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events, Safety laboratory values and ECG findings', 'timeFrame': '3 months'}, {'measure': 'Immunological reaction', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Tumorigenesis', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripheral Artery Disease', 'Peripheral Vascular Disease', 'Critical limb ischemia'], 'conditions': ['Peripheral Artery Disease', 'Peripheral Vascular Disease', 'Critical Limb Ischemia']}, 'descriptionModule': {'briefSummary': 'The The purpose of this study is to determine the safety of PLX-PAD single dose, Intra-muscular injection for the treatment of CLI patients.', 'detailedDescription': 'PLX-PAD are mesenchymal-like stromal cells derived from a full term placenta, termed PLX-PAD, and intended for the treatment of Critical Limb Ischemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with ABI \\< 0.4 or/and TBI \\< 0.4 or transcutaneous partial pressure of oxygen ≤ 30 mmHg pO2 at the foot.\n2. Rutherford category 4-5\n3. No acceptable options for re-vascularisation as confirmed by angiographic imaging results or by color flow duplex ultrasound obtained within 6 months prior screening visit and signed approval of vascular surgeon.\n4. In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.\n\nExclusion Criteria:\n\n1. Uncontrolled hypertension (defined as diastolic blood pressure \\> 110 mmHg or systolic blood pressure \\> 180 mmHg during screening).\n2. Poorly controlled diabetes mellitus (HbA1c \\> 9%)\n3. Wounds with severity greater than Grade 2 on the Wagner Scale\n4. Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina pectoris - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged\n5. ST segment elevation myocardial infarction and/or TIA/CVA within six (6) months prior to enrollment. Patients with severe congestive heart failure (i.e. NYHA Stage IV)\n6. In the opinion of the investigator, the patient is unsuitable for cellular therapy.'}, 'identificationModule': {'nctId': 'NCT00919958', 'briefTitle': 'Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pluristem Ltd.'}, 'officialTitle': "Phase I Study of Intramuscular (IM) Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia. PLX-PAD Are Mesenchymal-like Stromal Cells Derived From a Full Term Placenta. These Placental Adherent Stromal Cells (ASCs) Are Expanded in the Company's Proprietary PluriXTM 3D Bioreactor System. PLX Cells Are Immune Privileged and Possess Immunomodulatory Properties.", 'orgStudyIdInfo': {'id': 'PLX-PAD 1202-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PLX-PAD low dose', 'interventionNames': ['Biological: PLX-PAD IM injection']}, {'type': 'EXPERIMENTAL', 'label': 'PLX-PAD intermediate dose', 'interventionNames': ['Biological: PLX-PAD IM injection']}, {'type': 'EXPERIMENTAL', 'label': 'PLX-PAD high dose', 'interventionNames': ['Biological: PLX-PAD IM injection']}], 'interventions': [{'name': 'PLX-PAD IM injection', 'type': 'BIOLOGICAL', 'description': 'Single treatment; multiple injections', 'armGroupLabels': ['PLX-PAD high dose', 'PLX-PAD intermediate dose', 'PLX-PAD low dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Franziskus-Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Prof. Carsten Tschöpe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pluristem Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}