Placental Tissue Application for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Arthur L Burnett

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Nitrates, Androgens, Radiation therapy

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

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing whether using preserved placental tissue during prostate cancer surgery can help men recover sexual function and bladder control better. The tissue is placed over nerves to protect and heal them. Men with good sexual function before surgery are being studied.

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.

How is the treatment Lyopreserved Placental Tissue (LPT) unique for prostate cancer?

Lyopreserved Placental Tissue (LPT) is unique because it uses placental tissue, which is known for its regenerative properties, to potentially aid in healing and tissue regeneration. This approach is different from traditional prostate cancer treatments, which typically involve surgery, radiation, or chemotherapy, as it leverages the natural healing components of the placenta.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins Hospital Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Biochemical characterization of pure dehydrated binate amniotic membrane: role of cytokines in the spotlight. [2018] Placental allografts used for tissue regeneration differ in membrane compositions and processing techniques. A uniquely folded dehydrated binate amniotic membrane (DBAM) was biochemically characterized to evaluate its potential role in wound healing.

2. United States pubmed.ncbi.nlm.nih.gov

Tumor Take Rate Optimization for Colorectal Carcinoma Patient-Derived Xenograft Models. [2018] Background. For development of individualized treatment on a routine basis, transfer of patients' tumor tissue in a xenograft model (i.e., generation of patient-derived xenografts (PDX)) is desirable for molecular, biochemical, or functional analyses. Drawbacks are dissatisfactory tumor take rates, the necessity of fast tumor tissue processing, and extensive logistics demanding teamwork of surgeons, pathologists, and laboratory researchers. Methods. The take rates of ten colorectal cancer (CRC) tissue samples in immunodeficient mice were compared after direct cryopreservation and after a 24 h cooling period at 4°C prior to cryopreservation. Additionally, the effect of simultaneous Matrigel application on the take rates was investigated. Beside take rates, tumor growth characteristics and cell culture success were analyzed. Results. Tumor takes of CRC tissue samples were significantly improved after Matrigel application (8 versus 15 takes, p = 0.04). As expected, they diminished furthermore after 24 h cooling. Application of Matrigel could counteract this decrease significantly (2 versus 7 takes, p = 0.03). Cumulative take rate after cryopreservation was satisfactory (70%). Conclusion. Matrigel application after 24 h delay in tissue processing facilitates CRC PDX model development. These data help developing strategies for individualized tumor therapies in the context of multicenter clinical studies and for basic research on primary patient tumors.

3. United States pubmed.ncbi.nlm.nih.gov

Experience in Using Fetal Membranes: The Present and New Perspectives. [2018] The placenta is an accessible source of tissues for transplantation. Placental transplants have been used in wound treatment because of the basic function of the placenta and its nutritious properties and structure.

4. England pubmed.ncbi.nlm.nih.gov

Management of a chronic radiation necrosis wound with lyopreserved placental membrane containing viable cells. [2023] This case report describes management of a chronic radiation wound in a patient with multiple comorbidities using a lyopreserved placental membrane containing viable cells (vLPM). Positive outcomes suggest that vLPM provides a good conservative management option for patients with compromised wound healing due to radiation and comorbidities.

5. Netherlands 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. [2020] The human placenta provides a bountiful and noncontroversial source of stem cells which have the potential for regeneration of injured tissue. These cells may restore erectile function after neurovascular tissue injury such as that seen in radical pelvic surgeries and pelvic trauma.