Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
NCT ID: NCT06738576
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2024-12-16
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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single dose of 40 million HC016
They will receive 1 single dose 1 dose of 40 million cells of HC016 at a concentration of 10 million cells/mL. N=40
allogeneic mesenchymal stem cells
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.
Saline solution
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
Placebo
Placebo implantation is carried out in the same way as the drug implantation
Interventions
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allogeneic mesenchymal stem cells
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
Placebo implantation is carried out in the same way as the drug implantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
FEMALE
No
Sponsors
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Responsible Party
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Principal Investigators
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Carmen González Enguita, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Locations
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Hospital Universitario del Henares
Coslada, Madrid, Spain
Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Madrid, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Universitario Infanta Elena
Valdemoro, Madrid, Spain
Hospital Universitario General de Villalba.
Villalba, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Manuel Fernández Arjona, PhD
Role: primary
Jose Medina Polo, PhD
Role: primary
Miguel Sánchez Encinas, PhD
Role: primary
Santiago Alonso Bartolomé, PhD
Role: primary
Other Identifiers
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2024-514833-39-00
Identifier Type: CTIS
Identifier Source: secondary_id
SUITH
Identifier Type: -
Identifier Source: org_study_id
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