Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

NCT04534010 | Terminated Results DMC FDA Device

• 2 other identifiers: IRB-55153BRS0117
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Grafts With Complete Healing

  Complete is defined as when the graft is \>99% epithelialized. Degree of healing will be based on visual assessment by the surgeon and central reviewer with the following metrics on a visual analog scale (VAS): epithelialization (0-100%); granulation (0-100%); overall healing (0-100%). Photographs will be taken using a standardized 3d imaging device, stored and transmitted securely to a central reviewer for independent review.

  3, 6 and 12 months

Study Arms (1)

NACgraft patients

EXPERIMENTAL

uni- or bilateral engraftment surgery will be performed

Device: NACgraft

Interventions

NACgraft DEVICE

Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts. A NACgraft is a novel decellularized cadaveric implant derived from human nipples.

NACgraft patients

Eligibility Criteria

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

You may qualify if:

• Patient age 18-65
• Patient desires NAC grafting ≥3 months after autologous breast reconstruction
• Patient agrees to sleep on back until grafts healed (6 weeks)
• Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks)
• Patient agrees to not undergo NAC tattooing until completing study (12 months)
• Patient is able to understand and willing to sign informed consent.

You may not qualify if:

• History of delayed wound healing
• history of Vitamin C deficiency
• history of diabetes (Type I or Type II)
• current BMI\<18.5 or \>40 kg/m,
• patient has any other uncontrolled comorbidity.
• Patient has a history of allergic reaction to any decellularized biologic matrix product.
• Patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months.
• Patient is currently receiving radiation or chemotherapy or received radiation to the breast wall.
• Patient has a history of prior NAC reconstruction
• Patient has had NAC tattooing.
• Patient is pregnant, breastfeeding or planning to become pregnant during the study period.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Early termination led to small numbers of subjects analyzed.

Results Point of Contact

• Title: Arash Momeni, MD, FACS
• Organization: Stanford University

amomeni@stanford.edu

(650) 723-6189

Study Officials

• Geoffrey C Gurtner

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 1, 2020
• Study Start: April 28, 2021
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)