Completed

NCT Number: NCT01399307

Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue

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.

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Key information

Conditions

Soft Tissue Mass Removal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blair Plastic Surgery, Altoona, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Liposuction

Procedure

Elective Liposuction

Primary outcomes

• 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 outcomes

To compare the effectiveness of 2 different digestive enzymes in randomly selected set of samples

Time frame: one month
To measure the amount of residual digestive enzyme after the procedure

Time frame: one month
To determine the time and cost of supply during the procedure

Time frame: one month
To conclude logistic barriers (transport and testing of cells)

Time frame: one month
Obtaining cultures to detect potential contamination by pathogenes

Time frame: one month

Sponsors and collaborators

Lead sponsor

Antria

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jul 21, 2011
Registry last updated: Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.