Urinary Incontinence StressPhase 1SUITH)NCT06738576
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
A Phase 1 study testing allogeneic mesenchymal stem cells in people with Urinary Incontinence Stress, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Urinary Incontinence Stress
- What is being tested?
- allogeneic mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesSpain
- Study dates
- 16 Dec 2024to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 5 recruiting
- Recruiting
Hospital Universitario del Henares
Coslada, Madrid, 28822
Manuel Fernández Arjona, PhD
- Recruiting
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Mariano García Arranz, PhD, +34915504800, mariano.garcia@quironsalud.es
Carmen Énguita, PhD
- Recruiting
Hospital Universitario Doce de Octubre
Madrid, Madrid, 28041
Jose Medina Polo, PhD
- Recruiting
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
Miguel Sánchez Encinas, PhD
- Active, not recruiting
Hospital Universitario Infanta Elena
Valdemoro, Madrid, 28342
- Recruiting
Hospital Universitario General de Villalba.
Villalba, Madrid, 28400
Santiago Alonso Bartolomé, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Urinary Incontinence Stress
- Being tested
- allogeneic mesenchymal stem cells, Placebo
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic mesenchymal stem cellsDrug
Cell implantation is carried out in the following steps:
- - Patient anesthesia
- - Identification of the external urinary sphincter and the incompetent area responsible for incontinence through intraurethral cystoscopy.
- - Resuspension of the cells by gentle manual shaking of the vials. Once the cells are resuspended, they will be used immediately.
- - 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.
- - Cellular remains, if any, and the vials used will be eliminated following the usual procedures used for the management of hospital surgical waste.
PlaceboDrug
Placebo implantation is carried out in the same way as the drug implantation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (4)
The evaluation of the PAD-test
quantification of the amount of urine lost during the duration of the test (24h),
Measured: 3 moths and 6 months
Flowmetry values
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
Measured: 3 months
Quality of life SF-12 questionnaire
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
Measured: 3 moths and 6 months
Quality of life ICQ-SF questionnaire
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.
Measured: 3 moths and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start16 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen González Enguita, PhD, Principal investigator, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738576
- Sponsor's protocol ID
- SUITH
- Other IDs
- 2024-514833-39-00
- Acronym
- SUITH)
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06738576
- Acronym / sponsor ID
- SUITH) / SUITH
- Conditions
- Urinary Incontinence Stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single dose of 40 million HC016 | Experimental | Drug: allogeneic mesenchymal stem cellsThey will receive 1 single dose 1 dose of 40 million cells of HC016 at a concentration of 10 million cells/mL. N=40 |
| Saline solution | Placebo comparator | Drug: PlaceboThey 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic mesenchymal stem cellsCell 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. | Drug | single dose of 40 million HC016 |
| PlaceboPlacebo implantation is carried out in the same way as the drug implantation | Drug | Saline solution |
Primary outcome
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
4 secondary outcomes
The evaluation of the PAD-test
Time frame: 3 moths and 6 months
Flowmetry values
Time frame: 3 months
Quality of life SF-12 questionnaire
Time frame: 3 moths and 6 months
Quality of life ICQ-SF questionnaire
Time frame: 3 moths and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen González Enguita, PhD principal investigator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogeneic mesenchymal stem cells in people with Urinary Incontinence Stress, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen González Enguita, PhD (+34915504957, cgenguita@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with at least one of the complictations derived from the treatment. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.