What side effects are associated with this type of intervention?

Fat grafting for breast reconstruction can lead to several side effects, including prolonged edema, infections, contour irregularities, and necrosis or calcification of the injected fat. There is also a risk of fat emboli, which can lead to severe complications such as stroke and vision loss. Other common breast reconstruction techniques, such as the use of implants, may involve risks like infection, implant rupture, and capsular contracture.

What prior FDA approvals exist?

The FDA has approved several treatments for breast reconstruction, including the use of autologous fat grafting. This technique involves the transplantation of a patient's own fat cells to improve blood supply and tissue health, which can be particularly beneficial following radiation therapy. Autologous fat transfer is valued for its ability to enhance contour and volume without the risk of hypersensitivity or foreign body reactions. While specific drugs are not typically involved in fat grafting procedures, the process itself is a recognized and approved method for improving outcomes in breast reconstruction.

What other types of research exist?

Promising novel alternatives to fat grafting for breast reconstruction include the use of stem cell-based therapies, such as human embryonic stem cell-derived progenitors and induced pluripotent stem cells (iPSCs). These approaches aim to regenerate tissue and improve vascularization. Additionally, the use of bioengineered tissue scaffolds and growth factor-enriched matrices are being explored to enhance tissue integration and blood supply.

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Fat Grafting for Breast Reconstruction

N/A

Waitlist Available

Led By Christin A. Harless, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy

Have undergone mastectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how fat grafting affects blood flow in the breast skin of patients who have had a mastectomy and radiation therapy. The goal is to see if adding fat can improve skin health. Fat grafting has been increasingly recognized as a tool to rejuvenate irradiated skin and improve skin quality in patients who have undergone radiation therapy.

Who is the study for?

This trial is for breast cancer patients who have had a mastectomy and are undergoing immediate reconstruction with tissue expanders or implants that require radiation therapy. It's not open to those who do not wish to participate.

What is being tested?

The study is looking at how well blood flows through the skin of the breast after it has been treated with radiation and then fat grafting. This will help understand if fat grafting improves skin condition post-radiation.

What are the potential side effects?

While specific side effects are not listed, typical risks associated with fat grafting may include infection, bleeding, or changes in sensation around the treatment area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a breast cancer patient getting an implant or tissue expander with planned radiation therapy.

Select...

I have had a mastectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiation Fibrosis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Breast reconstruction with fat graftingExperimental Treatment1 Intervention

fat grafting

Group II: breast reconstruction without fat graftingActive Control1 Intervention

No Fat grafting

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fat grafting

2011

Completed Phase 2

~110

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast reconstruction treatments commonly include implants, flap procedures, and fat grafting. Fat grafting, or autologous fat transfer, involves harvesting fat from one part of the body and injecting it into the breast area. This technique improves blood supply and tissue health by promoting angiogenesis and providing a natural filler that integrates well with existing tissues. For breast reconstruction patients, these mechanisms are crucial as they enhance the aesthetic outcome, improve tissue viability, and reduce complications associated with poor blood supply and tissue damage.