Continence and Potency Following Multi-Layer Perinatal Issue alloGraft

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Post Operative Recovery

Treatments: Device: MLG (Multi-Layered Perinatal Issue Allograft) Allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT05081232

IRB00076844

Details and patient eligibility

About

The purpose of this research is to determine the effectiveness of using human Umbilical Cord (UC) allograft to help improve return to erectile function and bladder control in patients following robot-assisted radical prostatectomy (RARP).

Full description

Participation in this study will involve MLG (Multi-Layered Perinatal Tissue Allograft) allograft, which is implanted during the surgery. This allograft is currently FDA approved and used for several type of surgeries.

The Multi-Layered Perinatal Tissue Allograft- (MLG) is processed from tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act. The grafts are distributed by Samaritan Biologics, LLC; an FDA-registered tissue bank.

The MLG allograft will be placed on each neurovascular bundle (NVB) bilaterally.

MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick.

Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly.

Sex: Male

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male subjects with at least age of 30 to 65
2. Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy)
3. Primary diagnosis of organ confined untreated prostate cancer
4. Planned elective radical prostatectomy with bilateral nerve sparing technique
5. Negative urinalysis within 30 days prior to date of surgery
6. Patient has no erectile dysfunction (SHIM Score < 14 ) prior to date of surgery
7. Patient has the willingness to comply with instruction of the investigator
8. Patient has the willingness to comply with follow-up surveys
9. Have ability to provide full written consent.

Exclusion criteria

1. High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
2. Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
3. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
4. Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens
5. Patients with poor urinary control at baseline requiring the use of pads for leakage
6. Previous history of pelvic radiation
7. Previous history of simple prostatectomy or transurethral prostate surgery
8. Patients with obesity defined as BMI > 40 kg/m2
9. History of open pelvic surgery within 5 years except for hernia repair
10. Poorly controlled diabetes (A1C >8.5%)
11. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
12. Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
13. Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
14. In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months
15. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
16. 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Umbilical Cord Allograft Recipients

Experimental group

Description:

Male patients undergoing Robot Assisted Radical Prostectomy with bilateral nerve sparing technique will remain eligible to receive allograft during the surgery.

Treatment:

Device: MLG (Multi-Layered Perinatal Issue Allograft) Allograft