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

NCT06738576 | Recruiting Phase 1 DMC

• 2 other identifiers: SUITH2024-514833-39-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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.

Conditions

Urinary Incontinence Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The evaluation of the PAD-test

  3 moths and 6 months

• Flowmetry values

  3 months

• Quality of life SF-12 questionnaire

  3 moths and 6 months

• Quality of life ICQ-SF questionnaire

  3 moths and 6 months

Study Arms (2)

single dose of 40 million HC016

EXPERIMENTAL

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

Saline solution

PLACEBO COMPARATOR

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

Interventions

allogeneic mesenchymal stem cells DRUG

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.

single dose of 40 million HC016

Placebo DRUG

Placebo implantation is carried out in the same way as the drug implantation

Saline solution

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: This trial has been designed for women, because stress urinary incontinence (SUI) predominantly affects women between 20 and 50 years of age.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Subject's allergy to anesthetics

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (6)

Hospital Universitario del Henares

Coslada, Madrid, 28822, Spain

RECRUITING

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario Doce de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

RECRUITING

Hospital Universitario Infanta Elena

Valdemoro, Madrid, 28342, Spain

ACTIVE NOT RECRUITING

Hospital Universitario General de Villalba.

Villalba, Madrid, 28400, Spain

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen González Enguita, PhD

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen González Enguita, PhD

CONTACT

+34915504957; cgenguita@fjd.es

Mariano García Arranz, PhD

CONTACT

+34915504800; mariano.garcia@quironsalud.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 17, 2024
• Study Start: December 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

ES (6)