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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02216630
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):
Kimera Society Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Adipose Derived Stem Cell (ADSC) Therapy Phase 1 Phase 2

Detailed Description:
In the context of the proposed study, adipose derived stem cells (ASC) constitute an autologous cell product that is delivered to the patient via intra-venous injection. In this study, we propose to investigate the immunosuppressive potential of the non-manipulated non-cultured stromal vascular fraction obtained via liposuction. Endpoints will be measured both by improvement of the forced evacuation volume in one second (FEV1) and distance covered in a 6 minute walk distance test (6MWD). The stromal vascular fraction comprises stromal cells isolated from total fat via enzymatic digestion ex-vivo. These cells are not cultured but are isolated from adipose tissue using a sterile tissue process in under two hours. The process includes rinsing in a saline solution to remove red blood cells, draining, and enzymatic digestion (collagenase) which isolates endothelial cells from adipose tissue. Post-processing, the pellet obtained via centrifugation is filtered and delivered to the patient who remains sedated within the same ambulatory center.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Non-Randomized, Multi-center Study to Assess the Safety and Effects of Intravenous Implantation of Liposuction Derived Autologous Adipose-derived Stem Cells in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : August 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Adipose-Derived Stem Cell (ADSC) Therapy
This arm, as the sole arm, will consist of the ADSC treatment procedure. Intervention will consist of Adipose Derived Stem Cell (ADSC) Therapy
Drug: Adipose Derived Stem Cell (ADSC) Therapy
Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.

Primary Outcome Measures :
  1. FEV1 Decline [ Time Frame: 12 months ]
    The primary efficacy outcome will be a FEV1 decline of approximately or less than 30 ml at 12 month follow-up.

  2. Number of Adverse Events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Secondary Efficacy Objective [ Time Frame: 12 Months ]
    The secondary efficacy objective will be a decrease in six minute walking distance (6MWD) of less than 5% over one year.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 to 85, inclusive
  • A prior diagnosis of moderate to severe COPD

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02216630

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United States, Florida
Melvin Propis M.D.
Davie, Florida, United States, 33330
United States, Illinois
Chicago, Illinois, United States, 60061
United States, Nevada
Las Vegas
Las Vegas, Nevada, United States, 89030
United States, New York
New York
New York, New York, United States, 10001
United States, Texas
Dallas, Texas, United States, 75251
Sponsors and Collaborators
Kimera Society Inc

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Responsible Party: Kimera Society Inc Identifier: NCT02216630     History of Changes
Other Study ID Numbers: KS-SVF-1002
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by Kimera Society Inc:

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases