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

Korábbi kezelés

• Previous history of pelvic radiation
• Previous history of simple prostatectomy or transurethral prostate surgery
• Previous history of systemic therapy for prostate cancer
• Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
• 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

Más betegség

• History of open pelvic surgery within 5 years except for hernia repair
• Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments

Egyéb

• Patient has neurogenic bladder
• Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2

• 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