Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue

Not Applicable

Completed

• Conditions: Soft Tissue Mass Removal

• Registration Number: NCT01399307
• Lead Sponsor: Antria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-16
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-21
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
• 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	one month

Secondary Outcome Measures

Name	Time	Method
To compare the effectiveness of 2 different digestive enzymes in randomly selected set of samples	one month
To measure the amount of residual digestive enzyme after the procedure	one month
To determine the time and cost of supply during the procedure	one month
To conclude logistic barriers (transport and testing of cells)	one month
Obtaining cultures to detect potential contamination by pathogenes	one month

Trial Locations

Locations (2)

Blair Plastic Surgery; 🇺🇸 Altoona, Pennsylvania, United States

Indiana Regional Medical Center; 🇺🇸 Indiana, Pennsylvania, United States