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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age50+
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

About this trial

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 criteria

Qualifiers

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.

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • allogeneic mesenchymal stem cells
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups