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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Universitario del Henares
RECRUITING
Coslada
Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario Doce de Octubre
RECRUITING
Madrid
Hospital Universitario Rey Juan Carlos
RECRUITING
Móstoles
Hospital Universitario Infanta Elena
ACTIVE_NOT_RECRUITING
Valdemoro
Hospital Universitario General de Villalba.
RECRUITING
Villalba
Contact Information
Primary
Carmen González Enguita, PhD
cgenguita@fjd.es
+34915504957
Backup
Mariano García Arranz, PhD
mariano.garcia@quironsalud.es
+34915504800
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
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
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
Sponsors
Leads: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

This content was sourced from clinicaltrials.gov