Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue

NCT01399307 | Completed

• 1 other identifier: ACEP001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Soft Tissue Mass Removal

Keywords

Stem; Cell; Antria; Adipose; Stromal; Vascular; Fraction; Shahram; Shah; Rahimian

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (5)

• 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

Study Arms (1)

Elective Liposuction

OTHER

Procedure: Liposuction

Interventions

Liposuction PROCEDURE

Elective Liposuction

Elective Liposuction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female Age: 18 - 65 Scheduled for Liposuction Procedure Able to understand and provide written informed Consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Antria: lead

Study Sites (2)

Blair Plastic Surgery

Altoona, Pennsylvania, 16602, United States

Location

Indiana Regional Medical Center

Indiana, Pennsylvania, 15701, United States

Location

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Shahram Rahimian, MD

  Antria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2011
• First Posted: July 21, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

US (2)