Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
Study NCT ID:
NCT03909750
Status:
SUSPENDED
Last Update Posted:
2024-10-01
First Post:
2019-04-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'Withdrawn \\[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\\]', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety-Pulmonary Function: occurrence or frequency of adverse or severe adverse events during study', 'timeFrame': '6 months evaluate function and adverse events', 'description': 'Pulmonary Function as occurrence or frequency of adverse or severe adverse events during study'}], 'secondaryOutcomes': [{'measure': 'High Resolution Computerized Tomography - Lungs Fluidda Analysis', 'timeFrame': 'Baseline and 6 month Comparative Study', 'description': 'Fluidda Pulmonary Objective Analytics'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD', 'Respiratory Insufficiency']}, 'referencesModule': {'references': [{'pmid': '22314182', 'type': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': '16565429', 'type': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': 'Pulmonary Disorders are often categorized as Obstructive or Restrictive disorders. This study will establish two channels of investigation, one group within each type of pulmonary dysfunction. State-of-the-Art Objective analytics will be employed to track patients from baseline and 6 month intervals for up to one year.\n\nChronic 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. COPD is generally considered those who are able to better inspire air than to expel. Restrictive lung dysfunctions are generally considered those who are unable to achieve full inspiration function. Both can create some of the same symptoms, low Oxygen exchange, activity intolerance of exertion, shortness of breath (SOB), Pulmonary Hypertension, Loss of lung structure, Pneumothorax (in emphysema), may mandate supplemental Oxygen therapy, failure of airway mucus management (chronic bronchitis, bronchiectasis, etc), and other failure of lung function issues.\n\nRestrictive lung disorders represent a group of pulmonary function losses which are due to acquired fibrosis, congenital fibrotic disorders, functional airway damage (scarring), vascular abnormalities in arterial/venous supply,\n\nAir pollution and tobacco smoking, chemical inhalation damage, etc. are felt to be common contributor of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with anti-asthma bronchodilators, steroids, and a variety of combination of topical medications.\n\nStudy is an interventional study to document the safety and efficacy of use of cSVF in chronic broncho-pulmonary disease within both groups.', 'detailedDescription': 'Pulmonary Disorders, including both COPD \\& Restrictive Lung Disease (RLD) are often treated by limiting exposure to poor air quality, but there is no cure at this time. Most commonly, the patients are treated upon exacerbations, usually with some combination of inhalers, steroids, and medications which have proven to be ineffective other than addressing symptoms and trying to return to baseline symptom help. In addition, many attempted efforts are aimed at environmental changes, therapy include smoking cessation, vaccinations, respiratory rehabilitation, and attempts of use of bronchodilators and topical and systemic steroids. Many must resort to supplemental oxygen therapy, lung transplantation, and antibiotic supportive therapy during exacerbations.\n\nAs of 2013, COPD involve approximately 5% of 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.\n\nMost pulmonary function tests are, at best some help, but there is now a remarkable testing that is substantially more informative than standard flow measurements, as they include extensive anatomical and functional insights using High Resolution Computerized Tomography (HRCT) Lung. This protocol allows for direct evidence of the air trapping, lung volume capabilities, and three dimensional imaging of the airways and lungs themselves. This modality will be the primary comparative between baseline and 6 month post-therapy in determination of the status and changes than can be demonstrated following use of cellular stromal vascular fraction (cSVF). After isolation and concentration of the stem/stromal cells via digestive processing, deployment of such cellular elements are believed to engraft within the lung capillary tissues. Engraftment is not currently believed to be the primary elements following parenteral (IV) placement. Rather, it is believed to represent the paracrine secretory and communication between cell-to-cell or cell-to-matrix which communicates via exosomal and microvesicular contents that are released to influence the local niche (microenvironment). Via transfer of microRNA (mRNA) or mitoRNA (miRNA), stem cells are able to help other pulmonary cells replace or repair damaged elements associated with lung disorders. Further, these secretions and growth factor/cytokines availability have a positive influence on the small capillaries within the lung parenchyma, thereby likely to improve the gas exchange function within the lungs.\n\nTracking of oxygen saturation (at rest and activity), use of inhalers or other rescue effort reduction, reduction of oxygen supplement, and improved respiratory efforts will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented COPD or RLD by qualified Medical Provider\n* History of Pulmonary Function Deficits or supplemental oxygen therapy\n\nExclusion Criteria:\n\n* Cancer of the Lung\n* Patient's on chemotherapy or radiation for Cancer (or History within 5 years)\n* Inability to comply with Baseline and 6 month post-treatment HDCT lungs\n* General health or inability or unwillingness or ability to provide informed consent for study\n* History of lung transplantation\n* Life expectancy of \\<3 months due to concomitant illnesses\n* Exposure to any investigational drug of procedure within 1 month prior to study enrollment which may interfere with interpretation of outcomes\n* Illness which, in investigator's judgement, may interfere with patient's ability of comply with protocol, compromise patient safety, ability to provide informed consent or interfere with the interpretation of study outcomes.\n* Subjects with chronic immunosuppressive or chemotherapeutic medication.\n* Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result in opinion of investigators.\n* Subjects with documented Alpha 2 Antitrypsin Deficiency (inherited lung and liver disorder)\n* Patient with history of Hepatitis (except Hepatitis A history)"}, 'identificationModule': {'nctId': 'NCT03909750', 'acronym': 'cSVF-Lung', 'briefTitle': 'Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healeon Medical Inc'}, 'officialTitle': 'Use of Autologous Stem/Stromal Cells in Chronic Lung Disorders: Obstructive (COPD) and Restrictive (RLD)', 'orgStudyIdInfo': {'id': 'GARM 2 Lung'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lipoaspiration Microcannula 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': 'Isolation-Concentration Adipose cSVF ARM 2', 'description': 'Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)', 'interventionNames': ['Procedure: AD-cSVF']}, {'type': 'EXPERIMENTAL', 'label': 'Normal Saline IV ARM 3', 'description': 'Sterile Normal Saline IV with cSVF', 'interventionNames': ['Procedure: Normal Saline IV']}], 'interventions': [{'name': 'Lipoaspiration', 'type': 'PROCEDURE', 'description': 'Close syringe microcannula harvesting subdermal fat and perivascular stem/stromal cells', 'armGroupLabels': ['Lipoaspiration Microcannula ARM 1']}, {'name': 'AD-cSVF', 'type': 'PROCEDURE', 'description': 'Isolation of AD-cSVF', 'armGroupLabels': ['Isolation-Concentration Adipose 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': 'Global Alliance for Regenerative Medicine-USA', 'geoPoint': {'lat': 46.50992, 'lon': -114.09316}}, {'zip': 'Honduras', 'city': 'Roatán', 'state': 'Hn', 'country': 'Honduras', 'facility': 'Global Alliance of Regenerative Medicine (GARM) International', 'geoPoint': {'lat': 16.3229, 'lon': -86.53605}}], 'overallOfficials': [{'name': 'Glenn C Terry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Global Alliance for Regenerative Medicine (GARM-HN)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healeon Medical Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Robert W. Alexander, MD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}