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Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antria
ClinicalTrials.gov Identifier:
NCT01399307
First received: July 16, 2011
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large therapeutic potential for many rare and common diseases that impacts millions of patients worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to extract with minimally invasive procedures such as elective liposuction in large quantities and therefore may be a cost effective source for cellular therapies in a wide range of medical specialties. In this study we aim to demonstrate the efficacy of Antria Cell Preparation Process© in obtaining human adipose derived Stromal Vascular Fraction (SVF) by performing histology, various cell counts, multiple surface marker tests and measurement of the residual amount of digestive enzymes as a safety measure for human clinical trials.


Condition Intervention
Soft Tissue Mass Removal
Procedure: Liposuction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Proof of Concept Study to Demonstrate the Effectiveness of Antria Cell Preparation Process (Ace Process) in Extraction of Stromal Vascular Fraction From Adipose Tissue

Further study details as provided by Antria:

Primary Outcome Measures:
  • • To assess the success rate of our methodology in extraction of SVF from adipose tissue by performing cell count, cell viability tests and specific surface markers [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the effectiveness of 2 different digestive enzymes in randomly selected set of samples [ Time Frame: one month ] [ Designated as safety issue: No ]
  • To measure the amount of residual digestive enzyme after the procedure [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • To determine the time and cost of supply during the procedure [ Time Frame: one month ] [ Designated as safety issue: No ]
  • To conclude logistic barriers (transport and testing of cells) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Obtaining cultures to detect potential contamination by pathogenes [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Elective Liposuction Procedure: Liposuction
Elective Liposuction

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or Female Age: 18 - 65 Scheduled for Liposuction Procedure Able to understand and provide written informed Consent

Exclusion Criteria:

Diagnosis of any of the following medical conditions:

Active malignancy (diagnosed within 5 years) except for adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer) Active Infection Chronic use of NSAID's or Steroids On Radiotherapy or Chemotherapy agents Any other disease or condition that may alter the accuracy of study results (e.g. Severe Osteoporosis, Rheumatoid Arthritis and other autoimmune disorders)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399307

Locations
United States, Pennsylvania
Blair Plastic Surgery
Altoona, Pennsylvania, United States, 16602
Indiana Regional Medical Center
Indiana, Pennsylvania, United States, 15701
Sponsors and Collaborators
Antria
Investigators
Principal Investigator: Shahram Rahimian, MD Antria
  More Information

No publications provided

Responsible Party: Antria
ClinicalTrials.gov Identifier: NCT01399307     History of Changes
Other Study ID Numbers: ACEP001
Study First Received: July 16, 2011
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Antria:
Stem
Cell
Antria
Adipose
Stromal
Vascular
Fraction
Shahram
Shah
Rahimian

ClinicalTrials.gov processed this record on November 24, 2014