Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease

Chronic Heart Failure Clinical Trial

Official title:

Characterization of Adipose Derived Regenerative Cells (ADRCs) From Excess Tissue and Cells Designated for Discard From Patients With Chronic Heart Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02732106
• Other study ID #: CYTX-01
• 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

• Chronic Heart Failure
• Heart Diseases

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