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| Name | Class |
|---|---|
| Iniciativa Andaluza en Terapias Avanzadas | OTHER |
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This is a clinical trial phase I/II, double blind, randomized to compare in two groups of patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from the adipose tissue (CMMAd) in the treatment of the faecal incontinence.
In the phase of recruitment, of 20 months of duration, there will be included 16 participants who will be randomized to one of the groups of intervention (8 patients group CMMAd / 8 patients group placebo). The phase of follow-up of every patient will be 12 months, though, provided that these patients are seen regularly in the study sites of the study, once concluded his follow-up will be continued to be able to obtain safety information and efficacy to 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cells | Experimental | Autologous mesenchymal stem cells from the adipose tissue in an unique intralesional infusion with a dose of 40 million cells. |
|
| Ringer lactate solution | Placebo Comparator | Ringer lactate solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion of mesenchymal stem cells from adipose tissue | Drug |
| ||
| Infusion of placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the faecal incontinence diary | 12 months | |
| Anorectal manometry | 12 months | |
| Jorge-Wexner Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando de la Portilla, Dr. | Hospital U. Virgen del Rocio | Principal Investigator |
| Santiago Mera, Dr. | Hospital Regional U de Málaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Juan Ramón Jiménez | Huelva | 21005 | Spain | |||
| Fundación Jiménez Díaz |
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| Other |
|
| 12 months |
| Faecal Incontinence Quality of Life | 12 months |
| Madrid |
| 28040 |
| Spain |
| Hospital Regional U de Málaga | Málaga | 29010 | Spain |
| Hospital U Virgen del Rocio | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
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