Valdemoro

Researchers are evaluating the safety, feasibility, and initial effectiveness of using expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) to treat urinary incontinence in women over 50 years old. This phase I controlled trial aims to provide proof of concept and preliminary efficacy data by comparing the stem cell treatment to a saline placebo control group. The study focuses on women diagnosed with genuine or mixed stress urinary incontinence who have not responded to or refused rehabilitative or surgical treatments. Participants are divided into two groups: one receiving a single dose of 40 million HC106 cells and the other receiving a placebo saline solution. The treatment involves anesthesia, identification of the urinary sphincter area through cystoscopy, and injection of the cell suspension or placebo at two specific points around the sphincter. The injection is shallow to create a visible wheal, and any remaining cells or materials are properly discarded following hospital waste procedures. Throughout the study, patients will be monitored for complications and safety within 7 days following treatment. Researchers will assess the proportion of patients experiencing any treatment-related complications. Participants must provide informed consent and undergo urine cultures to ensure no active infection at enrollment. The overall study duration and additional long-term follow-up details are not specified but safety and initial efficacy outcomes will be closely observed during the trial period.

Researchers are evaluating the role of Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) with Mitomycin-C in patients with colon cancer that has spread to the peritoneum. The study focuses on patients undergoing complete surgical removal of these metastases combined with systemic chemotherapy. This Phase IV multicenter trial aims to determine if adding HIPEC with Mitomycin-C improves the time patients remain free from cancer recurrence in the peritoneal cavity, addressing limitations seen in previous studies using a different drug and treatment approach. Participants will be divided into two groups: one receiving complete cytoreductive surgery plus HIPEC with Mitomycin-C for 90 minutes, and the other undergoing surgery alone without HIPEC. The HIPEC procedure uses a dose of 35 mg/m2 Mitomycin-C delivered in a heated solution for 90 minutes with specific dose fractionation at set intervals. Only patients with limited volume peritoneal metastases, complete tumor removal, and colon (not rectal) cancer are included. Systemic chemotherapy is given before and/or after surgery as part of the treatment. During the study, patients will be closely monitored to confirm complete tumor removal and disease extent. Researchers will track peritoneal recurrence-free survival over three years as the primary outcome. Patients undergo assessments to ensure they meet health and surgical risk criteria before enrollment. Safety and disease progression are also regularly evaluated, with informed consent and ongoing follow-up care provided throughout the trial.

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy for people aged 12 to 65 who have mild to moderate allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. Participants are sensitized to grass and olive pollen, and the study is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. The study aims to measure combined symptoms and medication scores over 12 months to assess treatment impact. The study includes three groups receiving different treatments: two doses of purified and polymerized allergen extracts from a mixture of grasses and olive pollen (10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517) and a placebo group receiving a similar solution without active ingredients. Treatments are administered subcutaneously over one year. The study is double-blinded and controlled to compare safety and efficacy across groups. Participants will be involved for one year, during which they will record their symptoms and medication use via a smartphone app. Researchers will conduct clinical evaluations, skin tests, and measure specific IgE levels to monitor allergic responses. The main outcome is the Combined Symptoms and Medication Score (CSMS) after 12 months. Safety and treatment adherence will be closely monitored throughout the study period.

Researchers are evaluating surgical treatments for chronic lateral ankle instability, comparing arthroscopic reconstruction using a tendon allograft with the modified open Broström-Gould technique. This randomized, controlled clinical trial aims to determine if one method is more effective or safer than the other, using the clinical AOFAS scale to assess outcomes. Additional goals include comparing health outcomes, patient-reported pain levels, complication rates, and recovery times between the two surgeries. The study involves two surgical approaches: arthroscopic reconstruction with allograft tissue performed through small incisions using a camera, and an open surgery using the Broström-Gould technique where the patient's own ligaments are repaired via a lateral fibula incision. Patients will be randomly assigned to one of these two groups, stratified by age and functional demand. The recruitment is planned to start in the third quarter of 2025, lasting for 24 months, with a follow-up period extending 12 months after surgery. Participants will be monitored from the time of surgery through one year post-operation, with assessments including the clinical AOFAS scale, SP-36 health scale, and verbal numeric rating scale for pain. Researchers will track postoperative complications and the time it takes patients to return to daily activities. The total study duration is about three years, ending in the third quarter of 2028. Eligible patients are those diagnosed with chronic lateral ankle instability at a specific hospital, with a planned sample size of at least 36 participants.