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Also known as Dehydrated Human Amnion Chorion Membrane (dHACM), Human Amnion Membrane Allograft
BioDFence G3 Placental Tissue Membrane · 1 trial · 2 indications
Erectile function recovery among participants will be measured by the change in scores within the Sexual Domain of the Expanded Prostate Cancer Index Composite Short Form (EPIC26). The EPIC26 is a 26-item questionnaire used to measure health-related quality of life (HRQOL) among men with prostate cancer. The EPIC26 has five domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better HRQOL.
| Arm | Type | Description |
|---|---|---|
| Membrane Arm: dHACM Group | EXPERIMENTAL | Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months. |
| Control Arm: No dHACM Group | OTHER | Participants will undergo standard of care RARP surgery but will have no dehydrated Human Amnion Chorion Membrane (dHACM) placed after removal of the prostate. Participants will be in the group for approximately 12 months. |
| Name | Type | Description |
|---|---|---|
| BioDFence G3 Placental Tissue Membrane | BIOLOGICAL | The BioDFence G3 Placental Tissue Membrane is a three-layer tissue allograft consisting of amnion-chorion-amnion. Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP. The membrane will be cut into two longitudinal pieces and placed over each neurovascular bundle separately. |
| Robot-Assisted Radical Prostatectomy | PROCEDURE | Robot-assisted surgical removal of the prostate, administered standard of care. |
Inclusion Criteria: 1\. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM). Exclusion Criteria: 1. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED). 2. Men with baseline EPIC26 scores \< 50. 3. Patients w...
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BioDFence G3 Placental Tissue Membrane is a human amnion membrane allograft being studied in prostate cancer care. It is an investigational product developed by Integra LifeSciences Holdings Corporation, which trades under the ticker IART. It is being evaluated in men who have undergone radical prostatectomy, with a focus on recovery of erectile function after surgery.
BioDFence G3 Placental Tissue Membrane is being studied in men with prostate cancer who undergo radical prostatectomy, specifically to support early return of erectile function after the procedure. The research targets erectile dysfunction following radical prostatectomy, a common complication of prostate cancer surgery. It is investigational and has not been established as a treatment outside of clinical study.
BioDFence G3 Placental Tissue Membrane is developed by Integra LifeSciences Holdings Corporation, a company that trades on the Nasdaq under the ticker IART. Integra LifeSciences is the sponsor responsible for the clinical development of this human amnion membrane allograft in prostate cancer surgery recovery.
BioDFence G3 Placental Tissue Membrane is in Phase 2 clinical development. It is an investigational product and is not approved by the FDA. The Phase 2 study is currently active but no longer recruiting participants, and no completed trials of the product have been reported.
BioDFence G3 Placental Tissue Membrane is being evaluated in one clinical trial, NCT05842057, titled Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy. The Phase 2 study is active but not recruiting, has enrolled 118 male participants aged 40 years and older, is randomized, double blind, and controlled, and is conducted in the United States.