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Cryopreserved Umbilical Cord Allograft · 1 trial · 1 indication
Erectile function will be evaluated using the International Index of Erectile Function (IIEF)
| Arm | Type | Description |
|---|---|---|
| CLARIX CORD 1K | EXPERIMENTAL | They will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during Robot-Assisted Radical Prostatectomy (RARP). |
| Controls | ACTIVE_COMPARATOR | They will undergo RARP without adjunctive CLARIX® CORD 1K. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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 |
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 r...
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Cryopreserved Umbilical Cord Allograft is being studied for use in prostate cancer, specifically in patients undergoing radical prostatectomy. The investigational therapy is being evaluated in a Phase 2 clinical trial to assess its effects when used with or without the allograft during surgery.
Cryopreserved Umbilical Cord Allograft is being developed by Meridian Bioscience Inc, which trades under the ticker VIVO. The company is conducting a Phase 2 clinical trial to evaluate this investigational therapy in prostate cancer patients.
Cryopreserved Umbilical Cord Allograft is in Phase 2 clinical development. It is an investigational therapy being studied for prostate cancer, and it is not yet approved by regulatory authorities. The ongoing trial is active but not recruiting participants.
Cryopreserved Umbilical Cord Allograft is being evaluated in the AMNIOX CORD Study, registered as NCT04263025. This Phase 2 trial is comparing radical prostatectomy with and without the allograft in 100 male patients aged 30 years and older with prostate cancer in the United States.
Yes, Cryopreserved Umbilical Cord Allograft is classified as a monoclonal antibody. It is being investigated as a treatment for prostate cancer in a Phase 2 clinical trial, with the study actively enrolling patients in the United States.