Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

Completed · Phase 1/Phase 2

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

This will be an open-label, non-randomized multi-center study designed to assess the safety and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Key facts

Study ID

NCT02216630

Run by

Kimera Society Inc

People needed

26

Starts

2014-08-01

Expected to finish

2017-07-01

Last updated by the study team

2017-07-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 85, inclusive
• A prior diagnosis of moderate to severe COPD
• GOLD IIa, III, IV

You may not qualify if…

• Pregnant or lactating
• Life expectancy < 6 months due to concomitant illnesses.
• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
• Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
• Subjects on chronic immunosuppressive or chemotherapeutic therapy
• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
• Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).
• Unwilling and/or not able to give written consent
• Patient is positive for hepatitis (past history of Hepatitis A is allowed)
• Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
• Cerebral aneurysm clips

Where it is running

• Melvin Propis M.D. — Davie, Florida, United States
• Chicago — Chicago, Illinois, United States
• Las Vegas — Las Vegas, Nevada, United States
• New York — New York, New York, United States
• Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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