Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT02645305
Status:
UNKNOWN
Last Update Posted:
2016-01-01
First Post:
2015-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2015-12-30', 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SGOT', 'timeFrame': '1 month', 'description': 'The blood SGOT levels are thus elevated with liver damage'}, {'measure': 'SGPT', 'timeFrame': '1 month', 'description': 'The blood SGPT levels are thus elevated with liver damage'}], 'secondaryOutcomes': [{'measure': 'Respiration rate', 'timeFrame': '1 month, 6 months, 12 months'}, {'measure': '6 min walk test', 'timeFrame': '1 month, 6 months, 12 months'}, {'measure': 'rates of panic attacks', 'timeFrame': '1 month, 6 months, 12 months'}, {'measure': 'CRP concentration', 'timeFrame': '6 months, 12 months', 'description': 'The CRP concentration in the patients were evaluated before and after treatment for 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Safety and Efficacy', 'Adipose stem cells', 'Stem Cell therapy'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease. People with COPD have difficulties breathing, primarily due to the narrowing of their airways, this is called airflow obstruction.\n\nSome preclinical evaluations showed that COPD is closely related to chronic inflammation; therefore, this study aimed to use adipose-derived stem cells (ADSCs) in the form of non-expanded culture - that usually names as a stromal vascular fraction (SVF) in combination with activated platelet rich plasma (PRP) to treat this disease. Both SVF and PRP are autologous sources that obtained from adipose tissue and peripheral blood, respectively. This mixture is intravenously transfused into the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 40 to 80, inclusive\n* A prior diagnosis of moderate to severe COPD\n* GOLD IIa, III, IV\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Life expectancy \\< 6 months due to concomitant illnesses.\n* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.\n* Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results\n* Subjects on chronic immunosuppressive or chemotherapeutic therapy\n* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.\n* Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).\n* Unwilling and/or not able to give written consent\n* Patient is positive for hepatitis (past history of Hepatitis A is allowed)\n* Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient\n* Cerebral aneurysm clips"}, 'identificationModule': {'nctId': 'NCT02645305', 'briefTitle': 'Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Science Ho Chi Minh City'}, 'officialTitle': 'Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '2555/QD-BYT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.', 'interventionNames': ['Biological: Adipose derived stem cells']}], 'interventions': [{'name': 'Adipose derived stem cells', 'type': 'BIOLOGICAL', 'otherNames': ['Adipose derived stem cells and platelet rich plasma', 'ADSC and PRP'], 'description': 'Adipose derived stem cells that are isolated from adipose tissue are mesenchymal stem cells with high immune modulation capacity. Therefore, they can effectively modulate the immune system.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ho Chi Minh City', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Phuc V Pham, PhD', 'role': 'CONTACT', 'email': 'pvphuc@hcmuns.edu.vn', 'phone': '+84903870153'}, {'name': 'Phuc V Pham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}, {'city': 'Ho Chi Minh City', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Chien Vo Duc, MD.', 'role': 'CONTACT', 'email': 'myhanhchien@gmail.com'}], 'facility': 'Nguyen Tri Phuong Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}, {'city': 'Ho Chi Minh City', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Phuong Le Thi Bich, MSc., MD', 'role': 'CONTACT', 'email': 'drbichphuong@gmail.com'}, {'name': 'Phuong Le Thi Bich, MSc., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chien Vo Duc, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Van Hanh Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Science Ho Chi Minh City', 'class': 'OTHER'}, 'collaborators': [{'name': 'Van Hanh General Hospital', 'class': 'OTHER'}, {'name': 'Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet Nam', 'class': 'UNKNOWN'}, {'name': 'GeneWorld Ltd Co, Ho Chi Minh city, Viet Nam', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc, PhD.', 'investigatorFullName': 'Phuc Van Pham', 'investigatorAffiliation': 'University of Science Ho Chi Minh City'}}}}