AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 30, 2020

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2027

Conditions
Prostate Cancer
Interventions
BIOLOGICAL

Cryopreserved Umbilical Cord Allograft

"CLARIX® CORD 1K (Amniox Medical, Miami, FL) is an umbilical cord allograft processed using the patented CRYOTEK™ process by TissueTech Inc. to devitalize all living cells but retain the natural structural and biological characteristics relevant to this tissue \[43\]. CLARIX® CORD 1K (6x3 cm in size) will be cut into two longitudinal pieces (1.5 cm in width) and placed circumferentially around each NVB as a nerve wrap during RARP. CLARIX® CORD 1K has been in market since 2013 in the United States as a 361 human cell and tissue-based product (HCT/P) and is aseptically processed in compliance with current Good Tissue Practices (cGTP) as outlined in 21 CFR Part 1271."

PROCEDURE

Robot-Assisted Radical Prostatectomy

Robot-Assisted Radical Prostatectomy (RARP) is the most common surgical technique used to treat clinically localized prostate cancer however robot-assisted radical prostatectomy

Trial Locations (1)

07601

RECRUITING

Hackensack University Medical Center, Hackensack

All Listed Sponsors
lead

Hackensack Meridian Health

OTHER