Valdemoro

Researchers are evaluating the safety, feasibility, and initial effectiveness of expanded allogeneic mesenchymal stem cells derived from adipose tissue HC106 for treating urinary incontinence in women over 50 years old. This is a phase I, controlled trial aiming to gather proof of concept and preliminary data on this treatment for female urinary incontinence, specifically stress or mixed urinary incontinence with a predominance of effort-related leakage. The trial includes two groups one receiving a single dose of 40 million HC016 stem cells injected near the urinary sphincter, and a control group receiving a placebo saline solution injection. The cell or placebo injection is done under anesthesia and guided by cystoscopy to target specific points in the sphincter. The treatment involves one injection session, and the study follows participants to evaluate safety and effects. Participants will undergo assessments including a PAD-test, flowmetry, and quality of life questionnaires SF-12 and ICQ-SF at 3 and 6 months after treatment. Safety is monitored closely, especially for any complications within 7 days post-treatment. The total participation includes initial treatment and follow-up visits over at least 6 months to assess treatment impact and patient well-being.

Researchers are evaluating whether adding Hyperthermic Intraperitoneal Chemotherapy HIPEC with Mitomycin C after complete surgical removal of peritoneal metastases in patients with colon cancer affects the chance of cancer returning in the abdomen. This phase IV clinical trial addresses uncertainties from prior research by focusing on the time patients remain free from peritoneal recurrence rather than overall survival. It excludes rectal cancers and patients with extensive peritoneal disease or incomplete surgery to better understand HIPECs role in this setting. Participants are randomly assigned to one of two groups one receiving complete cytoreductive surgery plus HIPEC with Mitomycin C delivered at 35 mgm2 in a heated peritoneal dialysis solution for 90 minutes with dose fractionation, and the other receiving surgery alone without HIPEC. The study corrects previous trial shortcomings by increasing HIPEC infusion time and limiting patient selection based on cancer spread and surgery completeness. During the trial, participants will be monitored for peritoneal recurrence over three years, with assessments including imaging and disease-free survival measures. Researchers will also track postoperative complications within 90 days after surgery and evaluate quality of life at multiple points before surgery, after chemotherapy, and at one and two years. The trial aims to provide detailed information on recurrence patterns, survival, and patient well-being over three years following treatment.

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy in patients aged 12 to 65 who have mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitivity to grass and olive pollen. This randomized, double-blind, placebo-controlled phase 3 trial aims to study allergy treatments to improve symptoms and reduce medication use over one year. Participants are randomly assigned to one of three groups one receiving 10,000 TUmL MG01 plus 10,000 TUmL T517, another receiving 30,000 TUmL MG01 plus 10,000 TUmL T517, and a placebo group receiving the same solution without active ingredients. The allergen extracts come from a mixture of grasses and olive pollen, administered through subcutaneous injections. Treatment lasts for one year, evaluating different doses compared to placebo. During the study, participants will regularly record symptoms and medication use using a smartphone app. Researchers will monitor combined symptoms and medication scores as the primary outcome, along with medication-free days, symptom-free days, asthma exacerbations, quality of life tests for rhinitis and asthma, and immune response measures. Safety is closely followed through adverse reaction monitoring and immunological and security parameters over the 12-month treatment period.

This research aims to determine whether arthroscopic reconstruction with allograft offers real benefits compared to the modified open Brostrm-Gould technique for treating chronic lateral ankle instability. The study will use the clinical AOFAS scale to measure effectiveness and safety, and also assess health outcomes, patient pain levels, complication rates, and recovery time. It is a prospective, randomized, controlled clinical trial with two parallel groups, stratified by age and activity level. The trial compares two surgical methods one group will receive the modified Brostrm-Gould open surgery, which rebuilds damaged ligaments using the patients own tissue through an incision on the fibulas side, while the other group will undergo arthroscopic reconstruction using tendon allografts from tissue banks, performed through small incisions with arthroscopy. Both techniques are being evaluated for their outcomes and safety. Participants diagnosed with chronic lateral ankle instability will be followed for 12 months after surgery, with evaluations including clinical scales, pain assessments, and monitoring for complications. The total study period includes recruitment over 24 months and follow-up for a year, aiming to assess differences in recovery and return to normal activities. The study is led by Universidad Francisco de Vitoria and is expected to complete by 2028.