Placental Tissue Application for Prostate Cancer

Overseen By Arthur L Burnett

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Nitrates, Androgens, Radiation therapy

Disqualifiers: Peyronie's disease, Heart problems, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Lyopreserved Placental Tissue (LPT) used during a specific type of prostate cancer surgery can speed up recovery of sexual function and bladder control. The trial compares two groups: one receiving LPT placed over nerves during surgery and another following standard procedures without LPT. Men with good pre-surgery sexual health planning this type of surgery may be suitable for the trial. Participants will report their recovery progress at several points after surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking nitrate medications or have certain health conditions. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that Lyopreserved Placental Tissue (LPT) is likely to be safe for humans?

Research has shown that Lyopreserved Placental Tissue (LPT) is generally safe and well-tolerated. The FDA has approved this tissue for treating various medical conditions, such as wound care and diabetic foot ulcers. It has also been used successfully for surgical wounds and nerve protection, showing good results without major safety concerns.

Studies have found that LPT can improve recovery times, such as regaining bladder control after certain surgeries, without causing significant side effects. For instance, one study followed patients for an average of 41 months and found no serious safety issues. This suggests that LPT is a safe option for medical use.

Overall, while this trial tests a new use for LPT, its successful application in other medical areas provides reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard of care for prostate cancer, which often involves surgery, radiation, and hormone therapy, Lyopreserved Placental Tissue (LPT) offers a unique approach by utilizing human placental tissue. Researchers are excited about LPT because it is directly applied over the neurovascular bundles during surgery, potentially aiding in nerve preservation and recovery. This innovative method could lead to better outcomes in terms of nerve function and overall recovery, offering hope for improved quality of life post-surgery.

What evidence suggests that Lyopreserved Placental Tissue is effective for improving potency and continence after prostate cancer surgery?

Research has shown that Lyopreserved Placental Tissue (LPT) may aid healing and recovery after surgeries. LPT is already used in treating wounds and has shown promise in improving recovery, such as helping patients regain control over urination after prostate surgeries. Some studies suggest that LPT might accelerate nerve healing, potentially leading to quicker recovery of erectile function after prostate surgery. In this trial, one group of participants will receive LPT, labeled as Stravix, directly placed over the spared neurovascular bundles during bilateral nerve-sparing radical prostatectomy for prostate cancer. Researchers are investigating its use in prostate cancer surgeries to determine if it can help men regain erectile function and control over urination more effectively. While more data is still being collected on its use in prostate cancer, its success in other areas is encouraging. ^{1 2 4 5 6}

Who Is on the Research Team?

Arthur L Burnett

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Men aged 40-65 with good pre-surgery erectile function and localized prostate cancer (stage ≤ T2a, Gleason grade ≤ 7, PSA ≤ 10 ng/mL) planning a nerve-sparing robotic prostatectomy. Must be sexually active with a partner of at least 6 months and willing to attempt intercourse frequently post-surgery. Excludes those with uncontrolled blood pressure, certain medication use, spinal/brain surgery history, known sensitivities to specific reagents, substance abuse issues, heavy smoking history, penile deformity/Peyronie's disease, severe depression or organ problems.

Inclusion Criteria

You are willing to have sex at least 5 times per month after the surgery.

I am a man aged 40-65 with early-stage prostate cancer and a PSA of 10 or less.

I have been sexually active with my partner of 6+ months recently.

Exclusion Criteria

I have smoked a pack of cigarettes a day for 20 years.

I have a history of severe vision loss or specific eye conditions.

I have a history of heart issues like angina or heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo nerve-sparing robotic prostatectomy with or without LPT placement

1 day

1 visit (in-person)

Follow-up

Participants report erectile function and continence at multiple time points post-surgery

18 months

6 visits (in-person or virtual) at 1, 3, 6, 9, 12, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Lyopreserved Placental Tissue (LPT)

Trial Overview The trial is testing if applying Stravix lyopreserved placental tissue over neurovascular bundles during nerve-sparing robotic prostatectomy improves sexual and urinary functions compared to standard care. Men will report their erectile function and continence up to one year after surgery. The study aims to see how quickly men regain potency and continence.

How Is the Trial Designed?

Group I: Stravix Experimental Treatment 1 Intervention

Direct placement of LPT over the spared neurovascular bundles during bilateral nerve sparing radical prostatectomy for prostate cancer.

Group II: Standard of Care Placebo Group 1 Intervention

Standard care (no placement of tissue) bilateral nerve sparing radical prostatectomy for prostate cancer.

Lyopreserved Placental Tissue (LPT) is already approved in United States for the following indications:

Approved in United States as GRAFIX* Cryopreserved Placental Membrane for:

• Wound care
• Diabetic foot ulcers
• Acute and chronic surgical wounds
• Fistulas
• Nerve wraps

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Using Matrigel significantly improved the success rate of establishing patient-derived xenografts (PDX) from colorectal cancer samples, increasing tumor takes from 8 to 15 when applied directly, and from 2 to 7 after a 24-hour cooling period before cryopreservation.

The overall take rate after cryopreservation was satisfactory at 70%, indicating that with the right techniques, it is feasible to develop individualized treatment models for colorectal cancer using patient tumor tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Take Rate Optimization for Colorectal Carcinoma Patient-Derived Xenograft Models. Gock, M., Kühn, F., Mullins, CS., et al.[2018]

The use of lyopreserved placental membrane containing viable cells (vLPM) showed positive outcomes in managing a chronic radiation wound in a patient with multiple health issues, indicating its potential effectiveness.

vLPM may serve as a beneficial conservative treatment option for patients experiencing impaired wound healing due to radiation exposure and other underlying health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of a chronic radiation necrosis wound with lyopreserved placental membrane containing viable cells. Regulski, MJ., Danilkovitch, A., Saunders, MC.[2023]

The uniquely folded dehydrated binate amniotic membrane (DBAM) is confirmed to be chorion-free and retains an epithelial cell layer, which is important for its potential use in wound healing.

DBAM contains cytokines that promote the proliferation and migration of bone marrow stromal and stem cells, suggesting it could effectively stimulate tissue regeneration in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical characterization of pure dehydrated binate amniotic membrane: role of cytokines in the spotlight. Sane, MS., Misra, N., Quintanar, NM., et al.[2018]

From August 2011 to March 2017, 528 patients received biostatic human amnion transplants, demonstrating the effectiveness of amniotic membrane in treating wounds, particularly in cases of toxic epidermal necrolysis (Lyell's syndrome).

The use of placentas from transgenic pigs allowed for the preparation of significantly more grafts than human placentas, highlighting a promising alternative source for tissue transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience in Using Fetal Membranes: The Present and New Perspectives. Klama-Baryła, A., Łabuś, W., Kitala, D., et al.[2018]

In a rat model of pelvic neurovascular injury, injecting human placenta-derived stem cells (PSCs) significantly improved erectile function, with intracavernous pressure ratios reaching 72% of control levels by 6 weeks and 68% by 12 weeks after treatment.

Histological analysis showed substantial regeneration of neurons, endothelial cells, and smooth muscle cells in the treatment group, indicating that PSC therapy effectively promotes tissue recovery and may serve as a promising treatment to prevent erectile dysfunction following pelvic surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Changes in Erectile Function and Histological Architecture After Intracorporal Injection of Human Placental Stem Cells in a Pelvic Neurovascular Injury Rat Model. Gu, X., Thakker, PU., Matz, EL., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05366842

Study Details | NCT05366842 | Patient-Reported Erectile ... Surgical implantation of Lyopreserved Placental Tissue (LPT) is FDA approved and has been used extensively in wound care. The use is expanding and more ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11394080/

Impact of Cryopreserved Placental Allografts on ... Our data show improved continence recovery using CAM allografts. At a median follow-up of 41 months, there was no observed impact of BCR.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-10007

Lyopreserved Placental Tissue Wrap (StravixPL) During ... StravixPL may have anti-inflammatory and nourishing properties that may help heal the nerves which could result in a reduced amount of time of erectile ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33426577/

Cryopreserved placental tissue allograft accelerates time to ... Our study indicates that CPTA use appears to accelerate time to UC in age- and performance status-matched men undergoing RARP without increased risk of BCR.

5. grafixpl.com grafixpl.com/

Homepage | GRAFIX PL Lyopreserved Placental Membrane ... Wound closure outcomes suggest clinical equivalency between lyopreserved and cryopreserved placental membranes containing viable cells. Adv Wound Care (New ...

6. withpower.com withpower.com/trial/phase-2-prostate-cancer-3-2022-5dd42

Placental Tissue Application for Prostate Cancer The use of lyopreserved placental membrane containing viable cells (vLPM) showed positive outcomes in managing a chronic radiation wound in a patient with ...