Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-28 @ 4:04 PM
Study NCT ID:
NCT03239535
Status:
UNKNOWN
Last Update Posted:
2017-08-04
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'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': 'D016491', 'term': 'Peripheral Vascular 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '24 months', 'description': 'Number of adverse events reported'}, {'measure': 'Amputation-free survival', 'timeFrame': '24 months', 'description': 'Number of survived patients'}], 'secondaryOutcomes': [{'measure': 'Limb salvage from major amputation', 'timeFrame': '3, 6, 12, 24 months', 'description': 'Number of patients who avoided amputation'}, {'measure': 'Relief of the rest pain', 'timeFrame': 'Immediate, 3, 6, 12, 24 months', 'description': 'Rest pain will be measured using the rest pain scale'}, {'measure': 'Improvement in healing trophic disorders', 'timeFrame': 'Immediate, 3, 6, 12, 24 months', 'description': 'Assessment of the severity of trophic ulcers'}, {'measure': 'Improvement in perfusion by the ankle-brachial index', 'timeFrame': 'Immediate, 3, 6, 12, 24 months', 'description': 'Measurements of the ankle-brachial index'}, {'measure': 'Improvement in perfusion by radioisotope scintigraphy', 'timeFrame': 'Immediate, 3, 6, 12, 24 months', 'description': 'Radioisotope scintigraphy study'}, {'measure': 'Improvement in total walking distance (TWD) using a standard treadmill test', 'timeFrame': 'Immediate, 3, 6, 12, 24 months', 'description': 'Standard treadmill test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Limb Ischemia']}, 'descriptionModule': {'briefSummary': 'The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem cells for the treatment of critical limb ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females in the age group of 18-80 yrs of Caucasian origin.\n2. Peripheral artery disease (PAD) against the background of atherosclerosis and diabetes mellitus (DM)\n3. Critical lower limb ischemia (stages 3-4 by Fontaine-Pokrovsky or stages 4-6 by Rutherford)\n4. Patients with remaining symptoms of critical limb ischemia (CLI) in spite of the performed surgical (endovascular or open) treatment and continuing conservative therapy\n5. Patients with absent emergency indications to major amputation\n6. Patients planned for the reconstructive surgery with a questionable remote outcome due to compromised blood outflow\n7. Ankle Brachial Pressure Index (ABPI) ≤ 0.5 or ankle pressure ≤ 70 mm Hg\n8. Patients, if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8.5 %)\n9. On regular medication for hypertension if needed\n10. Normal liver and renal function (or having clinically insignificant deviations, according to the treating physician's opinion)\n11. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits\n\nExclusion Criteria:\n\n1. Humid gangrene or acute/chronic infection of lower limb.\n2. Dry gangrene with extensive foot lesion (\\> 1\\\\2).\n3. Acute arterial failure.\n4. Life-threatening conditions and predicted life expectancy of \\< 6 months.\n5. Presence of neoplasm or bone marrow disease\n6. Signs of active or chronic, including latent, haemorrhage\n7. Any acute or chronic infectious disease\n8. Renal failure determined as twofold or higher elevation of serum creatinine as compared to the upper normal limit\n9. Hepatic failure determined as the bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevated by two and more times over the upper normal limits\n10. Thrombocytopenia (platelet counts \\< 50,000 /µl), leukocytopenia (WBC \\< 4,000/µl), immunosuppressive therapy\n11. Pronounced neurological deficit\n12. Patients with gait disturbance for reasons other than CLI\n13. Patients not suitable for cell therapy, by the treating physician's opinion\n14. CLI patients requiring amputation at the proximal to the trans-metatarsal level\n15. Patients with Type I diabetes\n16. Patients having respiratory complications/left ventricular ejection fraction \\< 25%\n17. Stroke or myocardial infarction within last 3 months\n18. Patients who are contraindicated for X-ray angiography\n19. History of severe alcohol or drug abuse within 3 months of screening\n20. Pregnant and lactating women.\n21. Patients tested positive for HIV 1, hepatitis C virus (HCV), hepatitis B virus (HBV)\n22. Unsigned informed consent"}, 'identificationModule': {'nctId': 'NCT03239535', 'briefTitle': 'Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Federal Research Clinical Center of Federal Medical & Biological Agency, Russia'}, 'officialTitle': 'Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy', 'orgStudyIdInfo': {'id': 'MSC-CLI/FMBA/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cells', 'description': 'Mesenchymal stem cells, Intramuscular injection', 'interventionNames': ['Biological: Mesenchymal stem cells']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Normal saline, Intramuscular injection', 'interventionNames': ['Biological: Normal saline']}], 'interventions': [{'name': 'Mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['Mesenchymal stem cells']}, {'name': 'Normal saline', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mikhail A Konoplyannikov, PhD', 'role': 'CONTACT', 'email': 'mkonopl@mail.ru', 'phone': '+79154027268'}], 'facility': 'Federal Research Clinical Center of Federal Medical & Biological Agency', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Mikhail A Konoplyannikov, PhD', 'role': 'CONTACT', 'email': 'mkonopl@mail.ru', 'phone': '+79154027268'}], 'overallOfficials': [{'name': 'Vladimir P Baklaushev, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Deputy Director'}, {'name': 'Pavel Yu Orekhov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vascular Surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Research Clinical Center of Federal Medical & Biological Agency, Russia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}