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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514833-39-00 | EU Trial (CTIS) Number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic mesenchymal stem cells | Drug | Cell implantation is carried out in the following steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with at least one of the complictations derived from the treatment. | complications derived from treatment will be considered:
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of the PAD-test | quantification of the amount of urine lost during the duration of the test (24h), | 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 |
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Inclusion Criteria:
The predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort.
Exclusion Criteria:
This trial has been designed for women, because stress urinary incontinence (SUI) predominantly affects women between 20 and 50 years of age.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen González Enguita, PhD | Contact | +34915504957 | cgenguita@fjd.es | |
| Mariano García Arranz, PhD | Contact | +34915504800 | 3398 | mariano.garcia@quironsalud.es |
| Name | Affiliation | Role |
|---|---|---|
| Carmen González Enguita, PhD | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario del Henares | Recruiting | Coslada | Madrid | 28822 | Spain |
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|
| Placebo | Drug | Placebo implantation is carried out in the same way as the drug implantation |
|
| 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 | 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. | 3 moths and 6 months |
| Fundación Jiménez Díaz | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Hospital Universitario Doce de Octubre | Recruiting | Madrid | Madrid | 28041 | Spain |
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| Hospital Universitario Rey Juan Carlos | Recruiting | Móstoles | Madrid | 28933 | Spain |
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| Hospital Universitario Infanta Elena | Active, not recruiting | Valdemoro | Madrid | 28342 | Spain |
| Hospital Universitario General de Villalba. | Recruiting | Villalba | Madrid | 28400 | Spain |
|
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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