Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD) (cSVF-Lung)
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| ClinicalTrials.gov Identifier: NCT03909750 |
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Recruitment Status :
Recruiting
First Posted : April 10, 2019
Last Update Posted : January 22, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COPD Respiratory Insufficiency | Procedure: Lipoaspiration Procedure: AD-cSVF Procedure: Normal Saline IV | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Use of Autologous Stem/Stromal Cells in Chronic Lung Disorders: Obstructive (COPD) and Restrictive (RLD) |
| Actual Study Start Date : | April 10, 2019 |
| Estimated Primary Completion Date : | April 30, 2024 |
| Estimated Study Completion Date : | September 30, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lipoaspiration Microcannula ARM 1
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat
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Procedure: Lipoaspiration
Close syringe microcannula harvesting subdermal fat and perivascular stem/stromal cells |
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Experimental: Isolation-Concentration Adipose cSVF ARM 2
Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)
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Procedure: AD-cSVF
Isolation of AD-cSVF |
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Experimental: Normal Saline IV ARM 3
Sterile Normal Saline IV with cSVF
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Procedure: Normal Saline IV
Normal Saline IV containing AD-cSVF |
- 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
- High Resolution Computerized Tomography - Lungs Fluidda Analysis [ Time Frame: Baseline and 6 month Comparative Study ]Fluidda Pulmonary Objective Analytics
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented COPD or RLD by qualified Medical Provider
- History of Pulmonary Function Deficits or supplemental oxygen therapy
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909750
| Contact: Robert W Alexander, MD | 406.777.4477 | rwamd@garm-usa.com | |
| Contact: Nancy L Smith, ORT, CMA | 406.777.4477 | nancy@cybernet1.com |
| United States, Montana | |
| Global Alliance for Regenerative Medicine-USA | Recruiting |
| Stevensville, Montana, United States, 59870 | |
| Contact: Robert Alexander, MD 406-777-4477 rwamd@GARM-USA@gmail.com | |
| Contact: Nancy L Smith, CMA,ORT 406.777.5312 nancy@cybernet1.com | |
| Principal Investigator: Glenn C Terry, MD | |
| Principal Investigator: Robert W Alexander, MD | |
| Honduras | |
| Global Alliance of Regenerative Medicine (GARM) International | Recruiting |
| Roatan, Hn, Honduras, Honduras | |
| Contact: Glenn C Terry, MD +1.765.669.9141 info@GARM.com.hn | |
| Contact: Heather Terry +1.765.669.9141 info@GARM.com.hn | |
| Principal Investigator: | Glenn C Terry, MD | Global Alliance for Regenerative Medicine (GARM-HN) |
Publications of Results:
| Responsible Party: | Healeon Medical Inc |
| ClinicalTrials.gov Identifier: | NCT03909750 |
| Other Study ID Numbers: |
GARM 2 Lung |
| First Posted: | April 10, 2019 Key Record Dates |
| Last Update Posted: | January 22, 2020 |
| Last Verified: | November 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Respiratory Insufficiency Pulmonary Valve Insufficiency Respiration Disorders Respiratory Tract Diseases |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |