MicromastiaPhase 2GAASCNCT02116933

Grafting of Autologous Adipose Stromal Cell Trial

A Phase 2 study testing Adipose Derived Stem Cells and SVF Enriched Autologous Fat Grafting in people with Micromastia, run by Tower Outpatient Surgical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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

Who is it for?: Ages 21 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Micromastia
What is being tested?: Adipose Derived Stem Cells and SVF Enriched Autologous Fat Grafting
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Mar 2016
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

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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.
Patients must have normal renal function (demonstrated by a Creatinine ≤ 1.5 mg/dl,) and no urinary tract infection (less than 5 WBCs on UA and leukocyte esterase negative on U/A Dipstick). If a UTI is present, the patient may still enroll if this is treated pre-operatively
If a multigenerational family history of breast cancer or ovarian cancer is present, a surgical or medical oncologist must evaluate the patient to obtain pre-operative clearance and to provide reassurance that they do not need BRCA testing.
Patients with prior radiation to the chest wall (for Hodgkin's disease) may not be included in the study.

Who cannot join

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

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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.
Somatoform disorders .
Potential research participants with a substance abuse (e.g. alcoholism, medical narcotics (morphine, Vicodin, codeine, Percodan, etc.) illicit drug, prescription medications without a valid prescription, etc.) within 2 years of screening, and tobacco habit.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3.0 times the upper limit of normal, or creatinine exceeding 1.7 mg/dL (150 micromol/L) in men or 1.5 mg/dL (133 micromol/L) in women, hemoglobin ALC ≥ 10% at screening.
Research participants who are or have been receiving immunosuppressants such as Cyclosporin A or azathioprine within the past six weeks
Research participants on anticoagulants that cannot be stopped or corrected. Use of biologics, e.g. TNF-inhibitors, such as adalimumab, etanercept, infliximab, including any live vaccines within 3 months of the initial pain assessment period.
Research participants who are taking anticoagulants such as coumadin, fixed dose, non fractionated heparin or low molecular weight heparin (Lovenox).
Oral or parenterally administered systemic corticosteroids within 30 days prior to the initial pain assessment period.
Individuals largely or wholly incapacitated, e.g. bedridden or confined to a wheelchair, permitting little or no self-care.
Pregnant women, lactating mothers, women suspected of being pregnant, women who wish to be pregnant during the course of the clinical study.
Research participants who are presently or have been enrolled in other clinical trials within the past four weeks.

Trial locations and contacts

1 site in 1 country.

Cloe S Hakakian, BS contact

3106590705

cloe@aronowitzmd.com

Erin Welch, MA contact

3106590705

erin@aronowitzmd.com

United States1 site, 1 recruiting

University Stem Cell Center
Los Angeles, California, 90048
Cloe S Hakakian, BS, 310-659-0705, cloe@aronowitzmd.com
Joel A Aronowitz, MD
Recruiting

Other trials in United States

About this study

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

Read the detailed description

The purpose of this study is to objectively compare outcomes between autologous fat grafting breast augmentation and stromal vascular fraction enhanced autologous fat grafting for cosmetic breast augmentation in a carefully designed study.

Patients will be given the option of participating in one of two studies:

A small, level I study will compare AFG to SVF-enriched AFG in the same patient. One breast will be treated with AFG alone (control) and the other breast with SVF-enriched AFG (experimental).
A larger, level II study comparing AFG to SVF-enriched AFG in different patients. The patient will either receive AFG alone in both breasts or SVF-enhanced AFG in both breasts.

Conditions: Micromastia
Being tested: Adipose Derived Stem Cells, SVF Enriched Autologous Fat Grafting
Keywords: Autologous Fat Grafting, Breast Augmentation, Stromal Vascular Fraction, Adipose Derived Stem Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adipose Derived Stem CellsProcedure or surgery
Also called Stem Cells, Stromal Vascular Fraction, SVF
Adipose derived stem cells harvested from autologous lipoaspirate
SVF Enriched Autologous Fat GraftingProcedure or surgery
Also called Cell Assisted Lipotransfer, CAL, Lipofilling
Cell assisted lipotransfer

Study groups in NCT02116933
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Adipose Derived Stem Cells; Procedure: SVF Enriched Autologous Fat Grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Qualitative analysis of the size of the breasts at different time points to evaluate fat retention.
Measured: 1 month, 3 months, 6 months, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Mar 2016

First posted17 Apr 2014 (estimated)
Study startMar 2013
Primary completionMar 2016 (estimated)
Study completionMar 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for MicromastiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02116933
Sponsor's protocol ID: USCC001
Acronym: GAASC
Status last verified: May 2015
First submitted: 18 Mar 2014
Last updated: 13 May 2015
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 24281640
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.
PubMed 17102724
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.
PubMed 19912236
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.
PubMed 21124131
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.
PubMed 17763894
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.
PubMed 17415234
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.
PubMed 17415252
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.
PubMed 16936550
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.
PubMed 17312477

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Grafting of Autologous Adipose Stromal Cell Trial
ClinicalTrials.gov ID: NCT02116933
Acronym / sponsor ID: GAASC / USCC001
Conditions: Micromastia
Keywords: Autologous Fat Grafting, Breast Augmentation, Stromal Vascular Fraction, Adipose Derived Stem Cell
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: Tower Outpatient Surgical CenterUniversity, hospital or other
Study start: Mar 2013
Primary completion: Mar 2016 (estimated)
Study completion: Mar 2016 (estimated)
First posted: 17 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Patients will be given the option of participating in one of two studies:

A small, level I study will compare AFG to SVF-enriched AFG in the same patient. One breast will be treated with AFG alone (control) and the other breast with SVF-enriched AFG (experimental).
A larger, level II study comparing AFG to SVF-enriched AFG in different patients. The patient will either receive AFG alone in both breasts or SVF-enhanced AFG in both breasts.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Level I	Active comparator	Procedure: Adipose Derived Stem Cells, Procedure: SVF Enriched Autologous Fat GraftingA 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.
Level II	Active comparator	Procedure: Adipose Derived Stem Cells, Procedure: SVF Enriched Autologous Fat GraftingA 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.

Who may qualify

Ages: 21 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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.

Key exclusion criteria (25 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adipose Derived Stem CellsAlso: Stem Cells, Stromal Vascular Fraction, SVFAdipose derived stem cells harvested from autologous lipoaspirate	Procedure or surgery	Level I, Level II
SVF Enriched Autologous Fat GraftingAlso: Cell Assisted Lipotransfer, CAL, LipofillingCell assisted lipotransfer	Procedure or surgery	Level I, Level II

Primary outcome

Comparing change from baseline to outcomes between autologous fat grafting alone and stromal vascular fraction enriched fat grafting for breast augmentation
Time frame: 1 month, 3 months, 6 months, 1 year
Qualitative analysis of the breasts by a blind observer who will identify which breast is larger and looks better.

1 secondary outcome

Evaluate short term and long term survival of fat grafting versus SVF enriched fat grafting
Time frame: 1 month, 3 months, 6 months, 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
Background: PubMed 24281640Aronowitz 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.
Background: PubMed 17102724Atik 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.
Background: PubMed 19912236Yoshimura 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.
Background: PubMed 21124131Suga 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.
Background: PubMed 17763894Yoshimura 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.
Background: PubMed 17415234Rigotti 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.
Background: PubMed 17415252Piasecki 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.
Background: PubMed 16936550Coleman 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.
Background: PubMed 17312477Coleman 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cloe S Hakakian, BS contact

3106590705

cloe@aronowitzmd.com

Erin Welch, MA contact

3106590705

erin@aronowitzmd.com

Joel A Aronowitz, MD principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adipose Derived Stem Cells and SVF Enriched Autologous Fat Grafting in people with Micromastia, run by Tower Outpatient Surgical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cloe S Hakakian, BS (3106590705, cloe@aronowitzmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing change from baseline to outcomes between autologous fat grafting alone and stromal vascular fraction enriched fat grafting for breast augmentation (time frame: 1 month, 3 months, 6 months, 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02116933, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.