Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old (SUITH))

Phase II Clinical Trial to Determine the Safety and Efficacy of the Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106) in the Local Treatment of Female Urinary Incontinence in Women Over 50 Years of Age

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence Stress
• Intervention / Treatment: Drug: allogeneic mesenchymal stem cells; Drug: Placebo

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Carmen González Enguita, PhD; Phone Number: +34915504957; Email: cgenguita@fjd.es
• Study Contact Backup: Name: Mariano García Arranz, PhD; Phone Number: 3398 +34915504800; Email: mariano.garcia@quironsalud.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Fundacion Jimenez Diaz
    • Contact: Mariano García Arranz, PhD; Phone Number: +34915504800; Email: mariano.garcia@quironsalud.es
    • Principal Investigator: Carmen Énguita, PhD
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario Doce de Octubre
    • Contact: Jose Medina Polo, PhD
  • Madrid
    • Coslada, Madrid, Spain, 28822
      • Recruiting
      • Hospital Universitario del Henares
      • Contact: Manuel Fernández Arjona, PhD
    • Móstoles, Madrid, Spain, 28933
      • Recruiting
      • Hospital Universitario Rey Juan Carlos
      • Contact: Miguel Sánchez Encinas, PhD
    • Valdemoro, Madrid, Spain, 28342
      • Active, not recruiting
      • Hospital Universitario Infanta Elena
    • Villalba, Madrid, Spain, 28400
      • Recruiting
      • Hospital Universitario General de Villalba.
      • Contact: Santiago Alonso Bartolomé, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: allogeneic mesenchymal stem cells; Cell implantation is carried out in the following steps: - Patient anesthesia; - Identification of the external urinary sphincter and the incompetent area responsible for incontinence through intraurethral cystoscopy.; - Resuspension of the cells by gentle manual shaking of the vials. Once the cells are resuspended, they will be used immediately.; - 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.; - Cellular remains, if any, and the vials used will be eliminated following the usual procedures used for the management of hospital surgical waste.
Placebo Comparator: 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	Drug: Placebo; Placebo implantation is carried out in the same way as the drug implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of the PAD-test	quantification of the amount of urine lost during the duration of the test (24h),	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	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	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.	3 moths and 6 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Investigators: Principal Investigator: Carmen González Enguita, PhD, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SUITH; 2024-514833-39-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No