COPDPhase 1cSVF-LungNCT03909750
Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)
A Phase 1 study testing Lipoaspiration, AD-cSVF and Normal Saline IV in people with COPD and Respiratory Insufficiency, run by Healeon Medical Inc at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Respiratory Insufficiency
- What is being tested?
- Lipoaspiration, AD-cSVF and Normal Saline IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Apr 2019to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented COPD or RLD by qualified Medical Provider
- History of Pulmonary Function Deficits or supplemental oxygen therapy
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Global Alliance for Regenerative Medicine-USA
Stevensville, Montana, 59870
Honduras1 site
Global Alliance of Regenerative Medicine (GARM) International
Roatán, Hn, Honduras
About this study
Official title: Use of Autologous Stem/Stromal Cells in Chronic Lung Disorders: Obstructive (COPD) and Restrictive (RLD)
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.
Read more
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.
Read the detailed description
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.
As 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.
This 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.
Most 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.
Tracking 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.
- Conditions
- COPD, Respiratory Insufficiency
- Being tested
- Lipoaspiration, AD-cSVF, Normal Saline IV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoaspirationProcedure or surgery
Close syringe microcannula harvesting subdermal fat and perivascular stem/stromal cells
AD-cSVFProcedure or surgery
Isolation of AD-cSVF
Normal Saline IVProcedure or surgery
Normal Saline IV containing AD-cSVF
| Study group | Role | What they receive |
|---|---|---|
| Lipoaspiration Microcannula ARM 1 | Experimental | Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat Receives: Procedure: Lipoaspiration |
| Isolation-Concentration Adipose cSVF ARM 2 | Experimental | Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF) Receives: Procedure: AD-cSVF |
| Normal Saline IV ARM 3 | Experimental | Sterile Normal Saline IV with cSVF Receives: Procedure: Normal Saline IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety-Pulmonary Function: occurrence or frequency of adverse or severe adverse events during study
Pulmonary Function as occurrence or frequency of adverse or severe adverse events during study
Measured: 6 months evaluate function and adverse events
Secondary outcomes (1)
High Resolution Computerized Tomography - Lungs Fluidda Analysis
Fluidda Pulmonary Objective Analytics
Measured: Baseline and 6 month Comparative Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start10 Apr 2019
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healeon Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alexander, Robert W., M.D.
- Responsible party
- Sponsor
- Investigators
- Glenn C Terry, MD, Principal investigator, Global Alliance for Regenerative Medicine (GARM-HN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909750
- Sponsor's protocol ID
- GARM 2 Lung
- Acronym
- cSVF-Lung
- Status last verified
- Sep 2024
- First submitted
- 8 Apr 2019
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22314182Rabe 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.
PubMed 17507545Mathers 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.
PubMed 17132052Mahler 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.
PubMed 16636091Holland 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.
PubMed 23076942Kennedy 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.
PubMed 18073405Devereux 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.
PubMed 16690673Foreman 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.
PubMed 22793939O'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.
PubMed 16565429Mackay 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.
PubMed 22793945Puhan 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.
PubMed 21975749Saxena 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.
PubMed 2337756Kew 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.
PubMed 24615270COPD 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.
PubMed 23074435Bradley 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.
PubMed 16235359
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Stem/Stromal Cells in Chronic Lung Disorders: Obstructive (COPD) and Restrictive (RLD)
- ClinicalTrials.gov ID
- NCT03909750
- Acronym / sponsor ID
- cSVF-Lung / GARM 2 Lung
- Conditions
- COPD, Respiratory Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Healeon Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Alexander, Robert W., M.D.
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
As 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.
This 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.
Most 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.
Tracking 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lipoaspiration Microcannula ARM 1 | Experimental | Procedure: LipoaspirationAcquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat |
| Isolation-Concentration Adipose cSVF ARM 2 | Experimental | Procedure: AD-cSVFIsolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF) |
| Normal Saline IV ARM 3 | Experimental | Procedure: Normal Saline IVSterile Normal Saline IV with cSVF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented COPD or RLD by qualified Medical Provider
- History of Pulmonary Function Deficits or supplemental oxygen therapy
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipoaspirationClose syringe microcannula harvesting subdermal fat and perivascular stem/stromal cells | Procedure or surgery | Lipoaspiration Microcannula ARM 1 |
| AD-cSVFIsolation of AD-cSVF | Procedure or surgery | Isolation-Concentration Adipose cSVF ARM 2 |
| Normal Saline IVNormal Saline IV containing AD-cSVF | Procedure or surgery | Normal Saline IV ARM 3 |
Primary outcome
Safety-Pulmonary Function: occurrence or frequency of adverse or severe adverse events during study
Time frame: 6 months evaluate function and adverse events
Pulmonary Function as occurrence or frequency of adverse or severe adverse events during study
1 secondary outcome
High Resolution Computerized Tomography - Lungs Fluidda Analysis
Time frame: Baseline and 6 month Comparative Study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Results publication: PubMed 22314182Decramer 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.
- Results publication: PubMed 17507545Rabe 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.
- Results publication: PubMed 17132052Mathers 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.
- Results publication: PubMed 16636091Mahler 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.
- Results publication: PubMed 23076942Holland 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.
- Results publication: PubMed 18073405Kennedy 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.
- Results publication: PubMed 16690673Devereux 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.
- Results publication: PubMed 22793939Foreman 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.
- Results publication: PubMed 16565429O'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.
- Results publication: PubMed 22793945Mackay 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.
- Results publication: PubMed 21975749Puhan 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.
- Results publication: PubMed 2337756Saxena 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn C Terry, MD principal investigator
Global Alliance for Regenerative Medicine (GARM-HN)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lipoaspiration, AD-cSVF and Normal Saline IV in people with COPD and Respiratory Insufficiency, run by Healeon Medical Inc at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety-Pulmonary Function: occurrence or frequency of adverse or severe adverse events during study (time frame: 6 months evaluate function and adverse events). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909750, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.