NCT06738576 Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
| NCT ID | NCT06738576 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
| Condition | Urinary Incontinence Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-12-16 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate the feasibility and safety, obtaining initial efficacy data, of expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) for the treatment of urinary incontinence in women over 50 years of age.
Eligibility Criteria
Inclusion Criteria: * Women over 50 years old * Women with a clinical diagnosis of genuine or mixed stress urinary incontinence (SUI) with at least 6 months of evolution. Using the definitions of urinary incontinence internationally accepted by the ICS (International Continence Society): to. SUI: any involuntary loss of urine, immediately preceded by exertion. b. Mixed UI: any involuntary loss of urine, immediately preceded by exertion or an uncontrollable desire to urinate. The predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort. * Women in whom rehabilitative treatment has failed or patients who refuse to undergo rehabilitative or surgical treatment * Patients without active urinary tract infection (negative urine culture) at the time of recruitment and treatment * Signing of the informed consent form Exclusion Criteria: * Patients with a medical history of previous surgery for incontinence, prolapse or urological/gynecological/colorectal surgery * Major surgery or serious trauma of the subject in the previous semester * Women with mixed urinary incontinence, with predominant symptoms of urgency * History of high-pressure detrusor overactivity * Present infravesical obstruction, vesico-ureteral reflux or clinical history of urinary fistula (it will be ruled out depending on the case by urethrocystoscopy, urethrocystography and flowmetry). * Present any malignant neoplasm, unless it is basal cell or squamous cell carcinoma of the skin, or present a history of malignant tumors, unless they have been in remission during the previous 5 years. * Cardiopulmonary disease that, in the opinion of the investigator, is unstable or serious enough to exclude the patient from the study. * Medical or psychiatric illness of any type that, in the opinion of the researcher, may be a reason for exclusion from the study. * History of alcohol or other addictive substance abuse in the 6 months prior to inclusion * Subject's allergy to anesthetics
Contact & Investigator
Carmen González Enguita, PhD
PRINCIPAL INVESTIGATOR
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Frequently Asked Questions
Who can join the NCT06738576 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Urinary Incontinence Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06738576 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06738576 currently recruiting?
Yes, NCT06738576 is actively recruiting participants. Contact the research team at cgenguita@fjd.es for enrollment information.
Where is the NCT06738576 trial being conducted?
This trial is being conducted at Coslada, Spain, Madrid, Spain, Madrid, Spain, Móstoles, Spain and 2 additional locations.
Who is sponsoring the NCT06738576 clinical trial?
NCT06738576 is sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. The principal investigator is Carmen González Enguita, PhD at Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. The trial plans to enroll 60 participants.