A Phase 1 interventional study of allogeneic mesenchymal stem cells and Placebo in Urinary Incontinence Stress, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Recruiting at 6 sites in Spain. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Phase 1, Interventional, and Treatment
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.
It's a controlled trial, in phase I, proof of concept, safety and preliminary analysis of efficacy. It is planned to make 2 cohorts of patients, one with a single dose of 40 million HC016 and another group with saline solution (control).
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 60 is below the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 76 studies on the registry; 27 are open to participants now.
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The predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
They will receive 1 single dose 1 dose of 40 million cells of HC016 at a concentration of 10 million cells/mL. N=40
Drug: allogeneic mesenchymal stem cells
They will receive a single dose of the saline solution in which the HC016 cells are conditioned, which consists of lactated ringer's, glucosaline, sodium bicarbonate and human albumin. N=20
Drug: Placebo
Cell implantation is carried out in the following steps: 1. \- Patient anesthesia 2. \- Identification of the external urinary sphincter and the incompetent area responsible for incontinence through intraurethral cystoscopy. 3. \- Resuspension of the cells by gentle manual shaking of the vials. Once the cells are resuspended, they will be used immediately. 4. \- Injection of the cell suspension with a long, fine needle (those usually used in endoscopic puncture, \<22G) at 2 points of the sphincter that will coincide with the 3 o'clock and 9 o'clock position of the hands of a clock). The injection will be superficial, trying not to go deeper than 2 mm to create a wheal in each injection visible endoscopically. 5. \- Cellular remains, if any, and the vials used will be eliminated following the usual procedures used for the management of hospital surgical waste.
Placebo implantation is carried out in the same way as the drug implantation
Proportion of patients with at least one of the complictations derived from the treatment.
complications derived from treatment will be considered: * Complications during anesthesia. * Complications during treatment administration. * Peri- and postoperative complications. * Adverse effects during follow-up, whether or not associated with the drug
Time frame: 7 days
The evaluation of the PAD-test
quantification of the amount of urine lost during the duration of the test (24h),
Time frame: 3 moths and 6 months
Flowmetry values
improvement in the flowmetry values. It is expressed in cm3 (or ml) divided by second.and the normal values are between 50 and 80 mL/min
Time frame: 3 months
Quality of life SF-12 questionnaire
The score ranges between 0 and 100, where the higher score implies a better health-related quality of life Evaluate the change in the quality of life of the patients with respect to the baseline situation
Time frame: 3 moths and 6 months
Quality of life ICQ-SF questionnaire
Evaluate the change in the quality of life of the patients with respect to the baseline situation. Any score greater than zero is considered urinary incontinence.
Time frame: 3 moths and 6 months
Not enrolling at this site.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Mar 2027, 27 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: primary completion Dec 2025 → Mar 2027 and completion Dec 2025 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Allogeneic Adipose-derived Mesenchymal Stem Cells
Urinary Incontinence, Stress →
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz