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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03909750




Registration number
NCT03909750
Ethics application status
Date submitted
8/04/2019
Date registered
10/04/2019
Date last updated
1/10/2024

Titles & IDs
Public title
Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)
Scientific title
Use of Autologous Stem/Stromal Cells in Chronic Lung Disorders: Obstructive (COPD) and Restrictive (RLD)
Secondary ID [1] 0 0
GARM 2 Lung
Universal Trial Number (UTN)
Trial acronym
cSVF-Lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Respiratory Insufficiency 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Lipoaspiration
Treatment: Surgery - AD-cSVF
Treatment: Surgery - Normal Saline IV

Experimental: Lipoaspiration Microcannula ARM 1 - Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat

Experimental: Isolation-Concentration Adipose cSVF ARM 2 - Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)

Experimental: Normal Saline IV ARM 3 - Sterile Normal Saline IV with cSVF


Treatment: Surgery: Lipoaspiration
Close syringe microcannula harvesting subdermal fat and perivascular stem/stromal cells

Treatment: Surgery: AD-cSVF
Isolation of AD-cSVF

Treatment: Surgery: Normal Saline IV
Normal Saline IV containing AD-cSVF
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety-Pulmonary Function: occurrence or frequency of adverse or severe adverse events during study
Timepoint [1] 0 0
6 months evaluate function and adverse events
Secondary outcome [1] 0 0
High Resolution Computerized Tomography - Lungs Fluidda Analysis
Timepoint [1] 0 0
Baseline and 6 month Comparative Study

Eligibility
Key inclusion criteria
* Documented COPD or RLD by qualified Medical Provider
* History of Pulmonary Function Deficits or supplemental oxygen therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cancer of the Lung
* Patient's on chemotherapy or radiation for Cancer (or History within 5 years)
* Inability to comply with Baseline and 6 month post-treatment HDCT lungs
* General health or inability or unwillingness or ability to provide informed consent for study
* History of lung transplantation
* Life expectancy of <3 months due to concomitant illnesses
* Exposure to any investigational drug of procedure within 1 month prior to study enrollment which may interfere with interpretation of outcomes
* 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.
* Subjects with chronic immunosuppressive or chemotherapeutic medication.
* Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result in opinion of investigators.
* Subjects with documented Alpha 2 Antitrypsin Deficiency (inherited lung and liver disorder)
* Patient with history of Hepatitis (except Hepatitis A history)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Montana
Country [2] 0 0
Honduras
State/province [2] 0 0
Hn

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Healeon Medical Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Robert W. Alexander, MD
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.

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. 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.

Restrictive 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,

Air 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.

Study is an interventional study to document the safety and efficacy of use of cSVF in chronic broncho-pulmonary disease within both groups.
Trial website
https://clinicaltrials.gov/study/NCT03909750
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. Erratum In: Respiration. 2013;86(4):294.
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Glenn C Terry, MD
Address 0 0
Global Alliance for Regenerative Medicine (GARM-HN)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03909750