Is NCT06337942 recruiting in Los Angeles, CA?

Yes, NCT06337942 is currently recruiting participants at its Los Angeles, CA location. This bladder disease clinical trial is actively enrolling qualified participants.

How do I join the bladder disease clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Bladder Disease Clinical Trial in Los Angeles, CA

About This Bladder Disease Study in Los Angeles

The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are: * Is human bladder transplantation feasible and safe? * How will the new bladder function in terms of storage and emptying? Participants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant.

Sponsor: University of California, Los Angeles

Who Can Participate

Inclusion Criteria

Age 18-70 years

Positive history of one of the following:

Terminal bladder pathology resulting in poor compliance, recurrent refractory infections, and/or and resultant upper tract (kidney and ureteral) pathology, with possible resultant kidney disease.

Localized, non-metastatic, bladder cancer requiring radical cystectomy. In this protocol, the only patients with a history of urothelial cell carcinoma that has already been treated, with an appropriate disease-free interval would be considered. Moreover, only candidates requiring a joint kidney and bladder transplantation or patients with a pre-existing transplant, on standard immunosuppression, will be considered.

Patients that are on immunosuppression for pre-existing solid organ transplantation will be included in this study.

Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.

Patient has been previously fully vaccinated and boosted against COVID-19, or is willing to undergo timely vaccination. (a) Caretakers of the recipient will be strongly encouraged to be vaccinated.

Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations as needed. The patient (or assistant) must demonstrate proficiency in performing clean intermittent catheterization during pre-transplant workup.

No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of genitourinary transplantation. Examples of such medical conditions would include burden of atherosclerotic disease that would preclude vascular anastomosis, and psychiatric disorders that would preclude reliable adherence to medications.

No active co-existing psychosocial problems (i.e., alcoholism, drug abuse).

Negative crossmatch with donor.

Exclusion Criteria

Positive history of one of the following medical co-morbidities:

HIV (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis, varicella zoster virus

Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like hemophilia, Von-Willebrand's disease, protein C and S deficiency, thrombocythemia, thalassemia, sickle cell disease.

Mixed connective tissue diseases and collagen disorders (can result in poor wound healing after surgery), including: mixed connective tissue disorder; severe deforming rheumatoid arthritis; infectious, post-infectious, or inflammatory (axonal or demyelinating) neuropathy; Ehlers-Danlos syndrome;

lipopolysaccharidosis or amyloidosis (effects nerve regeneration)

Impaired liver function as evaluated by liver function panel, including the presence of hyperbilirubinemia, elevated AST/ALT, and the presence of secondary coagulopathy, measured by prothrombin, international normalized ratio, and partial thromboplastin time.

Severe anemia (hemoglobin \< 7 g/dL), leukopenia (WBC \< 3 x 109 cell/L), or thrombocytopenia (platelets \< 20 x109 cells/L).

Patient is either not vaccinated or is unwilling to undergo vaccination against COVID-19 prior to transplantation.

Oncology patient specific:

History of non-urothelial malignancy in past 5 years, with the exception of non-melanomatous skin cancer

History of malignancy involving metastases

Patients unable to receive adequate follow-up care and/or unable to receive immunosuppression due to geographic, financial or other reasons.

Patients with a smoking history who cannot demonstrate smoking cessation for a period of 6 months prior to listing and a desire to abstain from post-operative smoking will be excluded.

Records of poor medical compliance, documented psychological disorder(s), substance abuse or incomplete psychological clearance.

Particular attention will be paid to the candidate's compliance and their desire to undergo the offered procedure. While there is no "score" on any particular evaluation that would rule out a patient, certain factors can aid in the identification of patients who for example may not have the ability to comply with the medical directives necessary to care for a genitourinary transplant, or psychologically are not prepared for transplant, or who have unrealistic expectations about the transplant. The decision on eligibility is a team decision. All members of the team will discuss each candidate in a multidisciplinary meeting and reasons for concern over eligibility will be discussed at a Selection Committee Meeting. In circumstances where the candidate is considered to be less suitable, they could be given an opportunity to address these issues either through individual counseling or further education and then be reconsidered as a potential candidate. Every effort to prevent a request for allograft removal will be made.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT06337942) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Bladder Disease Treatment Options in Los Angeles, CA

If you're searching for bladder disease treatment options in Los Angeles, CA, this clinical trial (NCT06337942) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this clinical trial. You'll receive care from experienced bladder disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all bladder disease clinical trials near you to find additional studies recruiting in your area.

Bladder Disease Clinical Trial in Los Angeles, CA

Expert Care in Los Angeles

IRB Approved

No-Cost Care

Apply for This Los Angeles Location

Why Participate?

Simple Process