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

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous history of pelvic radiation
2. Previous history of simple prostatectomy or transurethral prostate surgery
3. Previous history of systemic therapy for prostate cancer
4. Patient has neurogenic bladder
5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
6. History of open pelvic surgery within 5 years except for hernia repair
7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
9. 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
10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

Conditions2

Locations1 site

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