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Donor nipple graft offers new hope for breast cancer reconstruction

NCT ID NCT04534010

Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new type of nipple reconstruction using a graft made from donated human nipples. Six breast cancer survivors who had already undergone breast reconstruction surgery received the graft. The goal was to see if the graft was safe and how long it took to heal, as well as how satisfied patients were with the results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
decellularized human nipple-areola complex graft
What this could lead to
If successful, this could offer a more natural option for nipple reconstruction after breast cancer, improving appearance and self-esteem.
What could go wrong
This was a very small pilot study (6 participants) that was terminated early, so results are limited. The graft may not heal properly or could have complications like infection or poor cosmetic outcome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Apr 2021

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Stanford University

    Stanford, California, 94304, United States

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Other studies related to the condition(s) this trial covers.