Clinical trial NCT01399307: Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Mass Removal
Keywords: Stem
Cell
Antria
Adipose
Stromal
Vascular
Fraction
Shahram
Shah
Rahimian
Lead sponsor: Antria
Sponsor class: INDUSTRY
First posted: 2011-07-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: • 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
timeFrame: one month
Secondary outcomes:
measure: To compare the effectiveness of 2 different digestive enzymes in randomly selected set of samples
timeFrame: one month
measure: To measure the amount of residual digestive enzyme after the procedure
timeFrame: one month
measure: To determine the time and cost of supply during the procedure
timeFrame: one month
measure: To conclude logistic barriers (transport and testing of cells)
timeFrame: one month
measure: Obtaining cultures to detect potential contamination by pathogenes
timeFrame: one month
Other outcomes:
Locations:
city: Altoona
country: United States
facility: Blair Plastic Surgery
state: Pennsylvania
city: Indiana
country: United States
facility: Indiana Regional Medical Center
state: Pennsylvania
Study officials:
affiliation: Antria
name: Shahram Rahimian, MD
role: PRINCIPAL_INVESTIGATOR
References: