Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-06 @ 9:04 AM
Study NCT ID:
NCT02946658
Status:
SUSPENDED
Last Update Posted:
2025-09-12
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'COVID-19 stopped patient ability to complete access for outcome analysis', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Pulmonary Function', 'timeFrame': '12 months Evaluate Function and Adverse Events', 'description': 'Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Respiratory Rate', 'timeFrame': '1 month, 6 month, 1 year', 'description': 'Measured rate clinically at rest'}, {'measure': 'GOLD Classification', 'timeFrame': '1 year', 'description': 'Global Initiative for Chronic Obstructive Lung Disease (GOLD) is a COPD staging system based on degree of airflow limitations (obstruction) and measured by pulmonary function studies'}, {'measure': 'Change from baseline 6 Minute Walk Test', 'timeFrame': '12 Months', 'description': 'Exercise capacity measured by distance a patient can walk in 6 minute timeframe'}, {'measure': 'Change from Baseline Lung X-Ray', 'timeFrame': '6 months, 12 months', 'description': 'standard flat film x-ray'}, {'measure': 'Change from Baseline SGOT Blood Testing', 'timeFrame': '1 Month', 'description': 'Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage'}, {'measure': 'Change from Baseline SGPT Blood Testing', 'timeFrame': '1 Month', 'description': 'Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage'}, {'measure': 'Pulmonary Function Testing', 'timeFrame': 'Baseline, 6 Months', 'description': 'Measure Baseline Pulmonary Function (FEV/FEVi Measure)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD, Emphysema'], 'conditions': ['Lung Disease']}, 'referencesModule': {'references': [{'pmid': '22314182', 'type': 'BACKGROUND', 'citation': 'Decramer M, Janssens W, Miravitlles M. Chronic obstructive pulmonary disease. Lancet. 2012 Apr 7;379(9823):1341-51. doi: 10.1016/S0140-6736(11)60968-9. Epub 2012 Feb 6.'}, {'pmid': '17507545', 'type': 'BACKGROUND', 'citation': 'Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.'}, {'pmid': '17132052', 'type': 'BACKGROUND', 'citation': 'Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.'}, {'pmid': '16636091', 'type': 'BACKGROUND', 'citation': 'Mahler DA. Mechanisms and measurement of dyspnea in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2006 May;3(3):234-8. doi: 10.1513/pats.200509-103SF.'}, {'pmid': '23076942', 'type': 'BACKGROUND', 'citation': 'Holland AE, Hill CJ, Jones AY, McDonald CF. Breathing exercises for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD008250. doi: 10.1002/14651858.CD008250.pub2.'}, {'pmid': '18073405', 'type': 'BACKGROUND', 'citation': 'Kennedy SM, Chambers R, Du W, Dimich-Ward H. Environmental and occupational exposures: do they affect chronic obstructive pulmonary disease differently in women and men? Proc Am Thorac Soc. 2007 Dec;4(8):692-4. doi: 10.1513/pats.200707-094SD.'}, {'pmid': '16690673', 'type': 'BACKGROUND', 'citation': 'Devereux G. ABC of chronic obstructive pulmonary disease. Definition, epidemiology, and risk factors. BMJ. 2006 May 13;332(7550):1142-4. doi: 10.1136/bmj.332.7550.1142. No abstract available.'}, {'pmid': '22793939', 'type': 'BACKGROUND', 'citation': 'Foreman MG, Campos M, Celedon JC. Genes and chronic obstructive pulmonary disease. Med Clin North Am. 2012 Jul;96(4):699-711. doi: 10.1016/j.mcna.2012.02.006. Epub 2012 Mar 6.'}, {'pmid': '22761482', 'type': 'BACKGROUND', 'citation': 'Brode SK, Ling SC, Chapman KR. Alpha-1 antitrypsin deficiency: a commonly overlooked cause of lung disease. CMAJ. 2012 Sep 4;184(12):1365-71. doi: 10.1503/cmaj.111749. Epub 2012 Jul 3. No abstract available.'}, {'pmid': '16565429', 'type': 'BACKGROUND', 'citation': "O'Donnell DE. Hyperinflation, dyspnea, and exercise intolerance in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2006 Apr;3(2):180-4. doi: 10.1513/pats.200508-093DO."}, {'pmid': '22793945', 'type': 'BACKGROUND', 'citation': 'Mackay AJ, Hurst JR. COPD exacerbations: causes, prevention, and treatment. Med Clin North Am. 2012 Jul;96(4):789-809. doi: 10.1016/j.mcna.2012.02.008. Epub 2012 Mar 16.'}, {'pmid': '21975749', 'type': 'BACKGROUND', 'citation': 'Puhan MA, Gimeno-Santos E, Scharplatz M, Troosters T, Walters EH, Steurer J. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD005305. doi: 10.1002/14651858.CD005305.pub3.'}, {'pmid': '2337756', 'type': 'BACKGROUND', 'citation': 'Saxena A, Watkin SW. Bilateral malignant testicular carcinoid. Br J Urol. 1990 Mar;65(3):302-3. doi: 10.1111/j.1464-410x.1990.tb14738.x. No abstract available.'}, {'pmid': '24615270', 'type': 'BACKGROUND', 'citation': 'Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014 Mar 10;2014(3):CD010115. doi: 10.1002/14651858.CD010115.pub2.'}, {'pmid': '23074435', 'type': 'BACKGROUND', 'citation': 'COPD Working Group. Long-term oxygen therapy for patients with chronic obstructive pulmonary disease (COPD): an evidence-based analysis. Ont Health Technol Assess Ser. 2012;12(7):1-64. Epub 2012 Mar 1.'}, {'pmid': '16235359', 'type': 'BACKGROUND', 'citation': "Bradley JM, O'Neill B. Short-term ambulatory oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD004356. doi: 10.1002/14651858.CD004356.pub3."}, {'pmid': '23235687', 'type': 'BACKGROUND', 'citation': 'Vollenweider DJ, Jarrett H, Steurer-Stey CA, Garcia-Aymerich J, Puhan MA. Antibiotics for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Dec 12;12:CD010257. doi: 10.1002/14651858.CD010257.'}, {'pmid': '23992090', 'type': 'BACKGROUND', 'citation': 'Inamdar AC, Inamdar AA. Mesenchymal stem cell therapy in lung disorders: pathogenesis of lung diseases and mechanism of action of mesenchymal stem cell. Exp Lung Res. 2013 Oct;39(8):315-27. doi: 10.3109/01902148.2013.816803. Epub 2013 Aug 30.'}, {'pmid': '24563632', 'type': 'BACKGROUND', 'citation': 'Conese M, Piro D, Carbone A, Castellani S, Di Gioia S. Hematopoietic and mesenchymal stem cells for the treatment of chronic respiratory diseases: role of plasticity and heterogeneity. ScientificWorldJournal. 2014 Jan 19;2014:859817. doi: 10.1155/2014/859817. eCollection 2014.'}, {'pmid': '25450456', 'type': 'BACKGROUND', 'citation': 'McQualter JL, Anthony D, Bozinovski S, Prele CM, Laurent GJ. Harnessing the potential of lung stem cells for regenerative medicine. Int J Biochem Cell Biol. 2014 Nov;56:82-91. doi: 10.1016/j.biocel.2014.10.012. Epub 2014 Oct 15.'}, {'pmid': '23364286', 'type': 'BACKGROUND', 'citation': 'Tzouvelekis A, Ntolios P, Bouros D. Stem cell treatment for chronic lung diseases. Respiration. 2013;85(3):179-92. doi: 10.1159/000346525. Epub 2013 Jan 29.'}, {'pmid': '23256721', 'type': 'BACKGROUND', 'citation': 'Tzouvelekis A, Laurent G, Bouros D. Stem cell therapy in chronic obstructive pulmonary disease. Seeking the Prometheus effect. Curr Drug Targets. 2013 Feb;14(2):246-52. doi: 10.2174/1389450111314020009.'}]}, 'descriptionModule': {'briefSummary': 'Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and interference with oxygen-carbon dioxide exchange.\n\nAir pollution and tobacco smoking are felt to be the most common cause of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with antiasthma bronchodilators.\n\nStudy is an interventional study to document the safety and efficacy of use of AD-cSVF in chronic broncho-pulmonary disease groups.', 'detailedDescription': 'COPD is often treated by limiting exposure to poor air quality, but there is no cure at this time. Attempted therapy include smoking cessation, vaccinations, respiratory rehabilitation, and attempts of use of bronchodilators and steroids. Many resort to supplemental oxygen therapy, lung transplantation, and antibiotic supportive therapy during exacerbations.\n\nAs of 2013, COPD involve approximately 5% pf the global populations (approximately 330 million). Most commonly it occurs approximately equally between men/women and result in about 3 million deaths per year. Estimates of economic costs are estimated to be more than 2.1 trillion dollars in 2010.\n\nThis study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prior Diagnosis of moderate to severe COPD\n* GOLD II a, III, IV\n\nExclusion Criteria:\n\n* Pregnant or Lactating Females\n* Life expectancy of \\< 3 months due to concomitant illnesses\n* Exposure to any investigational drug or procedure with 1 month prior to study entry or enrollment in concurrent study which may interfere with interpretation of study results\n* Illness which, in investigators judgement, may interfere with the patient' ability to comply with protocol, compromise patient safety, ability to provide informed consent to study, or interfere with interpretation of study outcomes\n* Subjects on chronic immunosuppressive or chemotherapeutic medications\n* Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result or in the opinion of investigator are not suitable to participate.\n* Subjects with documented Alpha-1 Antitrypsin Deficiency (Inherited lung and liver disorder)\n* Unwilling or not competent to understand and execute an informed consent agreement\n* Patients positive for Hepatitis (Hepatitis A history excepted)"}, 'identificationModule': {'nctId': 'NCT02946658', 'acronym': 'ADcSVF-COPD', 'briefTitle': 'Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healeon Medical Inc'}, 'officialTitle': 'Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders', 'orgStudyIdInfo': {'id': 'RGV-GARM 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lipoaspiration Arm 1', 'description': 'Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat', 'interventionNames': ['Procedure: lipoaspiration']}, {'type': 'EXPERIMENTAL', 'label': 'AD-cSVF Arm 2', 'description': 'Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)', 'interventionNames': ['Procedure: ADcSVF']}, {'type': 'EXPERIMENTAL', 'label': 'Normal Saline IV Arm 3', 'description': 'Normal Saline IV with AD-cSVF cells', 'interventionNames': ['Procedure: Normal Saline IV']}], 'interventions': [{'name': 'lipoaspiration', 'type': 'PROCEDURE', 'description': 'Closed syringe harvesting subdermal fat', 'armGroupLabels': ['Lipoaspiration Arm 1']}, {'name': 'ADcSVF', 'type': 'PROCEDURE', 'description': 'Isolation of AD-cSVF', 'armGroupLabels': ['AD-cSVF Arm 2']}, {'name': 'Normal Saline IV', 'type': 'PROCEDURE', 'description': 'Normal Saline IV containing AD-cSVF', 'armGroupLabels': ['Normal Saline IV Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59870', 'city': 'Stevensville', 'state': 'Montana', 'country': 'United States', 'facility': 'Regenevita LLC', 'geoPoint': {'lat': 46.50992, 'lon': -114.09316}}, {'city': 'Roatán', 'state': 'HN', 'country': 'Honduras', 'facility': 'Global Alliance for Regenerative Medicine (GARM)', 'geoPoint': {'lat': 16.3229, 'lon': -86.53605}}], 'overallOfficials': [{'name': 'Robert W Alexander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Healeon Medical Inc'}, {'name': 'Glenn C. Terry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Global Alliance for Regenerative Medicine (GARM)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healeon Medical Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Terry, Glenn C., M.D.', 'class': 'INDIV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Science', 'investigatorFullName': 'Robert W. Alexander, MD, FICS', 'investigatorAffiliation': 'Healeon Medical Inc'}}}}