Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease
1 other identifier
observational
20
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2013
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedApril 11, 2016
April 1, 2016
3.4 years
November 19, 2014
April 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adipose-Derived Regenerative Cells (ADRCs)- Cell Characterization
Cells will be evaluated regarding cell composition by flow cytometric assays.
Day 1
Eligibility Criteria
Patients with chronic heart disease
You may qualify if:
- Patients enrolled in the ATHENA clinical trial that donated their leftover material to be studied.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Kesten, MD
Cytori Therapeutics
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2014
First Posted
April 8, 2016
Study Start
April 1, 2013
Primary Completion
September 1, 2016
Study Completion
September 1, 2019
Last Updated
April 11, 2016
Record last verified: 2016-04