Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-07 @ 7:22 PM
Study NCT ID:
NCT02834858
Status:
UNKNOWN
Last Update Posted:
2017-04-06
First Post:
2016-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2016-07-09', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area of diabetic foot ulcers', 'timeFrame': '3 months', 'description': 'To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.'}], 'secondaryOutcomes': [{'measure': 'Improvement of transcutaneous oxygen partial pressure (TcPO2)', 'timeFrame': '3 months', 'description': 'Improvement of local perfusion.'}, {'measure': 'Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)', 'timeFrame': '3 months'}, {'measure': 'Pain (Visual-Analog Scale)', 'timeFrame': '3 months', 'description': 'Measure of the subjective symptom of pain.'}, {'measure': 'Walking distance (treadmill) if possible', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Umbilical Cord Mesenchymal Stem Cells'], 'conditions': ['Peripheral Vascular Disease', 'Ischemia', 'Diabetic Foot']}, 'descriptionModule': {'briefSummary': 'Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.', 'detailedDescription': 'Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.\n\nStem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of the investigators research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus Type 2 or Type 1\n* Age between 18-80 years\n* Chronic foot ulcer more than 6 weeks\n* No sufficient response to best standard care delivered for six weeks.\n* PAD up to Fontaine stage III or IV period\n* CLI with the ankle brachial index (index ankle-brachial, ABI) \\<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) \\<30mmHg\n\nExclusion Criteria:\n\n* HbA1c \\>12%\n* Hemoglobin \\<10 mg/dl\n* Creatinine clearance rate \\<30ml/min\n* Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, - HIV, B19 infection, herpes virus infection) and sepsis\n* Have accepted the treatment of stem cells or growth factors\n* Have a history of malignant disease\n* Pregnancy\n* Mental illness history\n* Abnormal coagulation function\n* Allergic reaction\n* Severe cardiac insufficiency (III-IV NYHA)\n* Using vasoactive substances'}, 'identificationModule': {'nctId': 'NCT02834858', 'briefTitle': 'Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Third Affiliated Hospital of Southern Medical University'}, 'officialTitle': 'Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications', 'orgStudyIdInfo': {'id': 'ThirdSouthernMedical1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Umbilical Cord Mesenchymal Stem Cells', 'description': 'Umbilical Cord Mesenchymal Stem Cells Infusion.', 'interventionNames': ['Biological: Umbilical Cord Mesenchymal Stem Cells']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'saline injection', 'interventionNames': ['Biological: saline']}], 'interventions': [{'name': 'Umbilical Cord Mesenchymal Stem Cells', 'type': 'BIOLOGICAL', 'description': 'stem cell acquisition, processing and reinfection, to evaluate the efficacy by using umbilical cord mesenchymal stem cells', 'armGroupLabels': ['Umbilical Cord Mesenchymal Stem Cells']}, {'name': 'saline', 'type': 'BIOLOGICAL', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhang qun', 'role': 'CONTACT', 'email': 'Zq1979@smu.edu.cn', 'phone': '020-62784060'}, {'name': 'Jie Shen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'the Third Affiliated Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jie Shen', 'role': 'CONTACT', 'email': 'shenjiedr@163.com', 'phone': '+86 13808893818'}], 'overallOfficials': [{'name': 'Jie Shen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Third Affiliated Hospital of Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jie Shen', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'Academy Military Medical Science, China', 'class': 'INDUSTRY'}, {'name': 'The Fifth Affiliated Hospital of Southern Medical University', 'class': 'OTHER'}, {'name': 'Southern Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Jie Shen', 'investigatorAffiliation': 'The Third Affiliated Hospital of Southern Medical University'}}}}