Actively Recruiting

Phase 1
Age: 50Years +
FEMALE
NCT06738576

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

Led by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Updated on 2025-05-01

60

Participants Needed

6

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over 50 years old
  • Clinical diagnosis of genuine or mixed stress urinary incontinence lasting at least 6 months
  • Predominance of stress-related urine loss when more than 50% of daily losses occur after exertion
  • Failure or refusal of rehabilitative or surgical treatment
  • No active urinary tract infection confirmed by negative urine culture at recruitment
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Previous surgery for incontinence, prolapse, or urological/gynecological/colorectal surgery
  • Major surgery or serious trauma within the last 6 months
  • Mixed urinary incontinence with predominant urgency symptoms
  • History of high-pressure detrusor overactivity
  • Presence of infravesical obstruction, vesico-ureteral reflux, or urinary fistula
  • Any malignant neoplasm except basal or squamous cell skin carcinoma, or malignant tumors not in remission for at least 5 years
  • Unstable or serious cardiopulmonary disease
  • Medical or psychiatric illness deemed exclusionary by the researcher
  • History of alcohol or substance abuse in the 6 months prior to inclusion
  • Allergy to anesthetics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Hospital Universitario del Henares

Coslada, Madrid, Spain, 28822

Actively Recruiting

2

Fundación Jiménez Díaz

Madrid, Madrid, Spain, 28040

Actively Recruiting

3

Hospital Universitario Doce de Octubre

Madrid, Madrid, Spain, 28041

Actively Recruiting

4

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain, 28933

Actively Recruiting

5

Hospital Universitario Infanta Elena

Valdemoro, Madrid, Spain, 28342

Active, Not Recruiting

6

Hospital Universitario General de Villalba.

Villalba, Madrid, Spain, 28400

Actively Recruiting

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Research Team

C

Carmen González Enguita, PhD

CONTACT

M

Mariano García Arranz, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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