Soft Tissue Mass Removal
Conditions
Keywords
Stem, Cell, Antria, Adipose, Stromal, Vascular, Fraction, Shahram, Shah, Rahimian
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.
Interventions
PROCEDURELiposuction
Elective Liposuction
Sponsors
Antria
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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)
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed