Sponsor study identifier
observational
20
1 country
4
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Human adipose tissue is now recognized as an acceptable, highly abundant source of adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and vessel-associated cells. Autologous adult regenerative cells are thought to promote healing of scarred or injured tissue. While the investigators are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. The use of ADRCs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in numerous clinical and preclinical studies around the world. While there is a considerable amount of information regarding the cellular composition of ADRCs isolated from healthy donors, basically there is no much data regarding the ADRC composition from cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia patients, that would otherwise be thrown away in waste, will be provided to researchers who will study these cells with the objective to characterize ADRCs derived from patients with a heart disease and to compare if a heart disease state does impact ADRC cell composition.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 19, 2014
Actual (reported)April 8, 2016
Actual (reported)September 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adipose-Derived Regenerative Cells (ADRCs)- Cell Characterization
Cells will be evaluated regarding cell composition by flow cytometric assays.
Day 1
Patients with chronic heart disease
Contact the study team to confirm eligibility.
Scripps Clinic - Torrey Pines, Scripps Green Hospital
La Jolla, California, 92037, United States
University of Florida
Gainesville, Florida, 32610, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Steven Kesten, MD
Cytori Therapeutics
First Submitted
November 19, 2014
First Posted
April 8, 2016
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Estimated (date passed)Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 11, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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