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

NCT ID: NCT02732106

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2019-09-30

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.

Conditions

Chronic Heart Failure

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytori Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Kesten, MD

Role: PRINCIPAL_INVESTIGATOR

Cytori Therapeutics

Locations

Scripps Clinic - Torrey Pines, Scripps Green Hospital

La Jolla, California, United States

University of Florida

Gainesville, Florida, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Texas Heart Institute

Houston, Texas, United States

Countries

United States

Other Identifiers

CYTX-01

Identifier Type: -

Identifier Source: org_study_id