Trial Outcomes & Findings for Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts (NCT NCT04534010)

Last Updated: 2025-12-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

3, 6 and 12 months

Results posted on

2025-12-17

Participant Flow

Unit of analysis: grafts

Participant milestones

Participant milestones
Measure	NACgraft patients Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts.
Overall Study STARTED	6 11
Overall Study COMPLETED	4 8
Overall Study NOT COMPLETED	2 3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NACgraft Patients n=6 Participants Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts.
Age, Categorical <=18 years	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=6 Participants
Age, Categorical >=65 years	1 Participants n=6 Participants
Sex: Female, Male Female	6 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	2 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants
Race (NIH/OMB) White	4 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Region of Enrollment United States	6 Participants n=6 Participants

PRIMARY outcome

Timeframe: 3, 6 and 12 months

Population: Participant who complete the protocol

Outcome measures

Outcome measures
Measure	NACgraft patients n=8 grafts Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts.
Number of Grafts With Complete Healing 3 months	8 grafts
Number of Grafts With Complete Healing 6 months	8 grafts
Number of Grafts With Complete Healing 12 months	8 grafts

Adverse Events

NACgraft patients

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	NACgraft patients n=6 participants at risk Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	16.7% 1/6 • 12 months

Other adverse events

Other adverse events
Measure	NACgraft patients n=6 participants at risk Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts.
Surgical and medical procedures Graft sloughing	33.3% 2/6 • 12 months

Additional Information

Arash Momeni, MD, FACS

Stanford University

Phone: (650) 723-6189

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place