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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02732106
Other study ID # CYTX-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 19, 2014
Last updated April 7, 2016
Start date April 2013
Est. completion date September 2019

Study information

Verified date April 2016
Source Cytori Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date September 2019
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients enrolled in the ATHENA clinical trial that donated their leftover material to be studied.

Exclusion Criteria:

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Florida Gainesville Florida
United States Texas Heart Institute Houston Texas
United States Scripps Clinic - Torrey Pines, Scripps Green Hospital La Jolla California
United States Minneapolis Heart Institute Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Cytori Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adipose-Derived Regenerative Cells (ADRCs)- Cell Characterization Cells will be evaluated regarding cell composition by flow cytometric assays. Day 1 No
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