Breast CancerNCT04534010

Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

A study testing NACgraft in people with Breast Cancer, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: NACgraft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 28 Apr 2021to 21 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94304

Other trials in United States

About this study

Official title: A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft

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
Being tested: NACgraft
Medical subject headings: Breast Neoplasms

What participants receive

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

NACgraftDevice
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.

Study groups in NCT04534010
Study group	Role	What they receive
NACgraft patients	Experimental	uni- or bilateral engraftment surgery will be performed Receives: Device: NACgraft

What is being measured

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

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.
Measured: 3, 6 and 12 months

Timeline

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

28 Apr 202121 Nov 2024

First posted1 Sep 2020
Study start28 Apr 2021
Primary completion21 Nov 2024
Study completion21 Nov 2024

Why it stopped: Sponsor decision due to low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04534010
Sponsor's protocol ID: IRB-55153
Other IDs: BRS0117
Status last verified: Nov 2025
First submitted: 20 Aug 2020
Last updated: 17 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft
ClinicalTrials.gov ID: NCT04534010
Acronym / sponsor ID: IRB-55153
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision due to low accrual
Enrolment: 6 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 28 Apr 2021 (actual)
Primary completion: 21 Nov 2024 (actual)
Study completion: 21 Nov 2024 (actual)
First posted: 1 Sep 2020 (actual)
Results: Posted 17 Dec 2025

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NACgraft patients	Experimental	Device: NACgraftuni- or bilateral engraftment surgery will be performed

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (11 listed)

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.

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
NACgraftPatients 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.	Device	NACgraft patients

Primary outcome

Number of Grafts With Complete Healing
Time frame: 3, 6 and 12 months
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.

Results and safety

Results posted to the registry on 17 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NACgraft patients	6	4

Primary outcome: Number of Grafts With Complete Healing

Time frame: 3, 6 and 12 months. Count of units. Unit: grafts

Measure	NACgraft patients n = 4
3 months	8
6 months	8
12 months	8

Population analysed: Participant who complete the protocol

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NACgraft patients	1 of 6 (16.7%)	2 of 6 (33.3%)	1 of 6

Limitations and caveats (from the sponsor): Early termination led to small numbers of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Geoffrey C Gurtner principal investigator

Stanford Universiy

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

Questions about this trial

What is this clinical trial studying?

A study testing NACgraft in people with Breast Cancer, run by Stanford University 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 17 Dec 2025. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Grafts With Complete Healing (time frame: 3, 6 and 12 months). 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 NCT04534010.

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 17 Dec 2025.