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

April 29, 2025 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Carmen González Enguita, PhD
  • Phone Number: +34915504957
  • Email: cgenguita@fjd.es

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Fundación Jiménez Díaz
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with at least one of the complictations derived from the treatment.
Time Frame: 7 days

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The evaluation of the PAD-test
Time Frame: 3 moths and 6 months
quantification of the amount of urine lost during the duration of the test (24h),
3 moths and 6 months
Flowmetry values
Time Frame: 3 months
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
Time Frame: 3 moths and 6 months
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
Time Frame: 3 moths and 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carmen González Enguita, PhD, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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