Grafting of Autologous Adipose Stromal Cell Trial

NCT02116933 | Unknown Phase 2

• 1 other identifier: USCC001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Grafting of autologous stromal cell trial is a prospective study comparing routine fat grafting versus stromal vascular fraction enriched fat grafting.

Conditions

Micromastia

Keywords

Autologous Fat Grafting; Breast Augmentation; Stromal Vascular Fraction; Adipose Derived Stem Cell

Outcome Measures

Primary Outcomes (1)

• Comparing change from baseline to outcomes between autologous fat grafting alone and stromal vascular fraction enriched fat grafting for breast augmentation

  Qualitative analysis of the breasts by a blind observer who will identify which breast is larger and looks better.

  1 month, 3 months, 6 months, 1 year

Secondary Outcomes (1)

• Evaluate short term and long term survival of fat grafting versus SVF enriched fat grafting

  1 month, 3 months, 6 months, 1 year

Other Outcomes (1)

• To define differences in indications, candidates, and populations that would benefit from fat grafting for breast enhancement versus traditional prosthetic augmentation

  1 month, 3 months, 6 months, 1 year

Study Arms (2)

Level I

ACTIVE COMPARATOR

A small, level I study will compare autologous fat grafting alone to stromal vascular fraction SVF enriched autologous fat grafting int he same patient. One breast will be treated with AFG alone and act as the control, and the other breast will be treated with SVF enriched AFG adn act as the experimental side exploring the efficacy of adipose derived stem cells.

Procedure: Adipose Derived Stem Cells; Procedure: SVF Enriched Autologous Fat Grafting

Level II

ACTIVE COMPARATOR

A larger, level II study comparing Autologous Fat Grafting to SVF enriched AFG in different patients. In this study, patients can choose to have AFG in both breasts or SVF enriched AFG in both breasts. The two patient groups will be compared. Here the group with the AFG in both breasts will be the control and the SVF enriched AFG in both breasts will be the experimental group exploring the efficacy of adipose derived stem cells.

Procedure: Adipose Derived Stem Cells; Procedure: SVF Enriched Autologous Fat Grafting

Interventions

Adipose Derived Stem Cells PROCEDURE

Adipose derived stem cells harvested from autologous lipoaspirate

Also known as: Stem Cells, Stromal Vascular Fraction, SVF

Level I; Level II

SVF Enriched Autologous Fat Grafting PROCEDURE

Cell assisted lipotransfer

Also known as: Cell Assisted Lipotransfer, CAL, Lipofilling

Level I; Level II

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must consent in writing to participate in the study by signing and dating an informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to completing any of the screening procedures.
• Female of any race, age 21-65.
• Patients must desire a small breast augmentation with a ½-1 cup size increase in their breast volume. (If they wish to have a larger breast size increase, then they must understand a secondary procedure may be required to achieve that size increase).
• Patients must have a normal physical exam with no breast masses, no nipple discharge, no fibrocystic disease, no axillary adenopathy and/or history of abnormal bleeding.
• Patients must not be pregnant or lactating when enrolled in the study and must agree to have a pregnancy test (urine or blood) prior to the surgical procedure. - The patient should also not be trying to get pregnant during the course of the study.
• Patients must have a stable weight and not be fluctuating in their weight (otherwise this will distort volumetric measurements of breast size post operatively, making it impossible to determine true augmentation volume from SVF-enriched AFG).
• Patients must also consent to be photographed before and after the procedure and at the end of the study.
• All patients in the level I (randomized) and level II (nonrandomized) part of the study must also consent to undergo ultrasound imaging of the breast prior to the procedure and after the procedure to evaluate and treat any oil-filled cysts that may arise due to the procedure.
• All patients in the level I (randomized) and level II (nonrandomized) part of the study must also consent to allow their results to be included in any scientific research, scientific publication, or presentations at scientific meetings.
• All patients in the level I and level II part of the study must also consent to allow their photos to be used for publication in scientific journals, internet website, and patient educational material such as brochures, before and after photos, and patient education videos.
• All patients in the study must also agree to have mammography done when indicated after the procedure.
• All patients in the study must agree to have a biopsy of any suspicious abnormality seen on mammography, ultrasound, or MRI during the study.
• Patients must not be anemic at the time of the procedure (Hg \< 10). If they are anemic at the time of enrollment, they can still be included in the study if the anemia is corrected pre-operatively with iron supplementation. This must be continued during the study to avoid any adverse reporting that may not be related to the procedure (i.e. anemia not caused by SVF-enriched fat grafting)
• Patients must have no history of abnormal bleeding during surgery, bruising and no personal/family history of coagulopathy.
• Patients must be off aspirin and other NSAIDs for two weeks prior to the procedure and have a normal blood coagulation panel within two weeks of surgery: Pts \> 150K, PT(INR) \< 1.3, APTT \<1.3×control.

You may not qualify if:

• Patients with a positive pregnancy test
• Patients with an abnormal breast exam
• Patients with a bleeding disorder who are on anticoagulants
• Patients with a known positive BRACA1 or BRCA2 gene mutation
• Patients who are anemic despite iron supplementation and treatment of the underlying cause of the anemia.
• Patients unwilling to have mammographic testing done before and after the procedure
• Patients with Fibromyalgia, regional pain syndrome, or chronic fatigue.
• Patients with positive human immunodeficiency (HIV), hepatitis B (HBV) or hepatitis C (HCV) at screening indicative of current of pass infection.
• Patients with a bleeding diathesis
• Patients with a positive urinalysis for pregnancy or UTI.
• Patients whose diabetes is not adequately controlled (HgA1c \> 7).
• Patients with a history of local anesthetic allergy.
• History, diagnosis, or signs and symptoms of clinically significant psychiatric disorder, including but not limited to
• Severe psychological disease (e.g. schizophrenia, manic-depressive disorder, severe depression, etc).
• Body dysmorphia syndromes, i.e., anorexia, bulimia, etc.

Sponsors & Collaborators

• Tower Outpatient Surgical Center: lead

Study Sites (1)

University Stem Cell Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (9)

• Aronowitz JA, Ellenhorn JDI. Adipose stromal vascular fraction isolation: a head-to-head comparison of four commercial cell separation systems. Plast Reconstr Surg. 2013 Dec;132(6):932e-939e. doi: 10.1097/PRS.0b013e3182a80652.

  PMID: 24281640 BACKGROUND

• Atik B, Ozturk G, Erdogan E, Tan O. Comparison of techniques for long-term storage of fat grafts: an experimental study. Plast Reconstr Surg. 2006 Dec;118(7):1533-1537. doi: 10.1097/01.prs.0000240806.19404.a8.

  PMID: 17102724 BACKGROUND

• Yoshimura K, Asano Y, Aoi N, Kurita M, Oshima Y, Sato K, Inoue K, Suga H, Eto H, Kato H, Harii K. Progenitor-enriched adipose tissue transplantation as rescue for breast implant complications. Breast J. 2010 Mar-Apr;16(2):169-75. doi: 10.1111/j.1524-4741.2009.00873.x. Epub 2009 Nov 12.

  PMID: 19912236 BACKGROUND

• Suga H, Eto H, Aoi N, Kato H, Araki J, Doi K, Higashino T, Yoshimura K. Adipose tissue remodeling under ischemia: death of adipocytes and activation of stem/progenitor cells. Plast Reconstr Surg. 2010 Dec;126(6):1911-1923. doi: 10.1097/PRS.0b013e3181f4468b.

  PMID: 21124131 BACKGROUND

• Yoshimura K, Sato K, Aoi N, Kurita M, Hirohi T, Harii K. Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg. 2008 Jan;32(1):48-55; discussion 56-7. doi: 10.1007/s00266-007-9019-4. Epub 2007 Sep 1.

  PMID: 17763894 BACKGROUND

• Rigotti G, Marchi A, Galie M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-1422. doi: 10.1097/01.prs.0000256047.47909.71.

  PMID: 17415234 BACKGROUND

• Piasecki JH, Gutowski KA, Lahvis GP, Moreno KI. An experimental model for improving fat graft viability and purity. Plast Reconstr Surg. 2007 Apr 15;119(5):1571-1583. doi: 10.1097/01.prs.0000256062.74324.1c.

  PMID: 17415252 BACKGROUND

• Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.

  PMID: 16936550 BACKGROUND

• Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. doi: 10.1097/01.prs.0000252001.59162.c9.

  PMID: 17312477 BACKGROUND

Study Officials

• Joel A Aronowitz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cloe S Hakakian, BS

CONTACT

3106590705; cloe@aronowitzmd.com

Erin Welch, MA

CONTACT

3106590705; erin@aronowitzmd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joel A. Aronowitz MD

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: April 17, 2014
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

US (1)