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

NCT04263025 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Pro2019-0452
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinary function.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Bilateral, nerve-sparing prostatectomy; Prostatectomy

Outcome Measures

Primary Outcomes (3)

• Erectile function

  Erectile function will be evaluated using the International Index of Erectile Function (IIEF)

  At three months post surgery

• Erectile function

  Erectile function will be evaluated using the International Index of Erectile Function (IIEF)

  At six months post surgery

• Erectile function

  Erectile function will be evaluated using the International Index of Erectile Function (IIEF)

  At twelve months post surgery

Secondary Outcomes (29)

• Potency endpoint

  6 weeks post op

• Potency endpoint

  3 months post op

• Potency endpoint

  6 months post op

• Potency endpoint

  12 months post op

• Return to continence

  At 6 weeks post surgery

Study Arms (2)

CLARIX CORD 1K

EXPERIMENTAL

They will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during Robot-Assisted Radical Prostatectomy (RARP).

Biological: Cryopreserved Umbilical Cord Allograft; Procedure: Robot-Assisted Radical Prostatectomy

Controls

ACTIVE COMPARATOR

They will undergo RARP without adjunctive CLARIX® CORD 1K.

Procedure: Robot-Assisted Radical Prostatectomy

Interventions

Cryopreserved Umbilical Cord Allograft BIOLOGICAL

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.

CLARIX CORD 1K

Robot-Assisted Radical Prostatectomy PROCEDURE

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

CLARIX CORD 1K; Controls

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Only male patients will be recruited as we are studying prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged between 30 and 70 years old
• Primary diagnosis of organ confined prostate cancer
• Scheduled to undergo bilateral, nerve-sparing RARP
• Patient has ICIQ-SF score \<6
• Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)
• Patient is willing to return for all visits as defined in the protocol
• Patient is willing to follow the instruction of the Investigator
• Patient has provided written informed consent

You may not qualify if:

• Previous history of pelvic radiation
• Previous history of simple prostatectomy or transurethral prostate surgery
• Previous history of systemic therapy for prostate cancer
• Patient has neurogenic bladder
• Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
• History of open pelvic surgery within 5 years except for hernia repair
• Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
• Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
• Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
• Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Stifelman, MD

  Chair of Urology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Seidman, RN

CONTACT

5519963749; Sharon.Seidman@hmhn.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 10, 2020
• Study Start: January 30, 2020
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)