Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 80
Updated:11/10/2018
Start Date:October 2016
End Date:December 2020
Contact:Robert W Alexander, MD
Email:rwamd@cybernet1.com
Phone:406.777.5312

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Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders

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.

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.

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)
We found this trial at
2
sites
Stevensville, Montana 59870
Principal Investigator: Glenn C Terry, MD
Phone: 406-777-5312
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Roatan, HN
Principal Investigator: Glenn C Terry, MD
Phone: +1.706.566.9141
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Roatan,
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