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Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01399307
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : January 19, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Soft Tissue Mass Removal Procedure: Liposuction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Elective Liposuction Procedure: Liposuction
Elective Liposuction

Primary Outcome Measures :
  1. • 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 ]

Secondary Outcome Measures :
  1. To compare the effectiveness of 2 different digestive enzymes in randomly selected set of samples [ Time Frame: one month ]
  2. To measure the amount of residual digestive enzyme after the procedure [ Time Frame: one month ]
  3. To determine the time and cost of supply during the procedure [ Time Frame: one month ]
  4. To conclude logistic barriers (transport and testing of cells) [ Time Frame: one month ]
  5. Obtaining cultures to detect potential contamination by pathogenes [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01399307

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

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Responsible Party: Antria Identifier: NCT01399307     History of Changes
Other Study ID Numbers: ACEP001
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by Antria: