Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Soft Tissue Mass Removal

Intervention / Treatment
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* Procedure: Liposuction


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Elective Liposuction<br> | Procedure: Liposuction<br>* Elective Liposuction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem, Cell, Antria, Adipose, Stromal, Vascular, Fraction, Shahram, Shah, Rahimian