Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue

NCT ID: NCT01399307

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-08-31

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.

Detailed Description

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Conditions

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Soft Tissue Mass Removal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Elective Liposuction

Group Type OTHER

Liposuction

Intervention Type PROCEDURE

Elective Liposuction

Interventions

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Liposuction

Elective Liposuction

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antria

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shahram Rahimian, MD

Role: PRINCIPAL_INVESTIGATOR

Antria

Locations

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Blair Plastic Surgery

Altoona, Pennsylvania, United States

Site Status

Indiana Regional Medical Center

Indiana, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ACEP001

Identifier Type: -

Identifier Source: org_study_id

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