Clinical trial NCT02946658: Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders
Official title: Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Lung Disease
Keywords: COPD, Emphysema
Lead sponsor: Healeon Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Terry, Glenn C., M.D.
First posted: 2016-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Air pollution and tobacco smoking are felt to be the most common cause of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with antiasthma bronchodilators.

Study is an interventional study to document the safety and efficacy of use of AD-cSVF in chronic broncho-pulmonary disease groups.

Detailed description: COPD is often treated by limiting exposure to poor air quality, but there is no cure at this time. Attempted therapy include smoking cessation, vaccinations, respiratory rehabilitation, and attempts of use of bronchodilators and steroids. Many resort to supplemental oxygen therapy, lung transplantation, and antibiotic supportive therapy during exacerbations.

As of 2013, COPD involve approximately 5% pf 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.

Eligibility criteria: Inclusion Criteria:

* Prior Diagnosis of moderate to severe COPD
* GOLD II a, III, IV

Exclusion Criteria:

* Pregnant or Lactating Females
* Life expectancy of \< 3 months due to concomitant illnesses
* Exposure to any investigational drug or procedure with 1 month prior to study entry or enrollment in concurrent study which may interfere with interpretation of study results
* Illness which, in investigators judgement, may interfere with the patient' ability to comply with protocol, compromise patient safety, ability to provide informed consent to study, or interfere with interpretation of study outcomes
* Subjects on chronic immunosuppressive or chemotherapeutic medications
* Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result or in the opinion of investigator are not suitable to participate.
* Subjects with documented Alpha-1 Antitrypsin Deficiency (Inherited lung and liver disorder)
* Unwilling or not competent to understand and execute an informed consent agreement
* Patients positive for Hepatitis (Hepatitis A history excepted)

Primary outcomes:
measure: Safety - Pulmonary Function
timeFrame: 12 months Evaluate Function and Adverse Events
Secondary outcomes:
measure: Change from Baseline Respiratory Rate
timeFrame: 1 month, 6 month, 1 year
measure: GOLD Classification
timeFrame: 1 year
measure: Change from baseline 6 Minute Walk Test
timeFrame: 12 Months
measure: Change from Baseline Lung X-Ray
timeFrame: 6 months, 12 months
measure: Change from Baseline SGOT Blood Testing
timeFrame: 1 Month
measure: Change from Baseline SGPT Blood Testing
timeFrame: 1 Month
measure: Pulmonary Function Testing
timeFrame: Baseline, 6 Months
Other outcomes:
Locations:
city: Stevensville
country: United States
facility: Regenevita LLC
state: Montana
city: Roatan
country: Honduras
facility: Global Alliance for Regenerative Medicine (GARM)
state: HN
Study officials:
affiliation: Healeon Medical Inc
name: Robert W Alexander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Global Alliance for Regenerative Medicine (GARM)
name: Glenn C. Terry, MD
role: PRINCIPAL_INVESTIGATOR
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