Clinical trial NCT03909750: Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)
Official title: Use of Autologous Stem/Stromal Cells in Chronic Lung Disorders: Obstructive (COPD) and Restrictive (RLD)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: COPD
Respiratory Insufficiency
Lead sponsor: Healeon Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Robert W. Alexander, MD
First posted: 2019-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Safety-Pulmonary Function: occurrence or frequency of adverse or severe adverse events during study
timeFrame: 6 months evaluate function and adverse events
Secondary outcomes:
measure: High Resolution Computerized Tomography - Lungs Fluidda Analysis
timeFrame: Baseline and 6 month Comparative Study
Other outcomes:
Locations:
city: Stevensville
country: United States
facility: Global Alliance for Regenerative Medicine-USA
state: Montana
city: Roatan
country: Honduras
facility: Global Alliance of Regenerative Medicine (GARM) International
state: Hn
Study officials:
affiliation: Global Alliance for Regenerative Medicine (GARM-HN)
name: Glenn C Terry, MD
role: PRINCIPAL_INVESTIGATOR
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