Hidradenitis suppurativa
Conditions
Brief summary
SAFETY: During the intervention, in the 24 hours afterwards and throughout the 24 months that the follow-up will last, adverse events, serious adverse events related to the investigational drug during the infusion will be evaluated as the main variable., EFFICACY: The combined remission of the treated draining fistula, defined as one that simultaneously meets the 4 criteria: Closure of all draining fistulous orifices present at the time of the inclusion of the patient in the study; Absence of suppuration after the vigorous digital pressure on the fistula; Absence of collections larger than 2 cm in the treated fistula, evaluated by blind ultrasound; And absence of inflammation evaluated by blind doppler ultrasound, in the 2 axes of the lesion.
Detailed description
Anatomical characteristics of the treated draining fistula: Location (armpits, groin, glutes, genital, perianal, submammary, others); Dimensions; Depth; And inflammatory activity., Clinical remission of the treated draining fistula, defined as the closure of all the draining fistula orifices at the beginning of the trial and absence of suppuration after application of vigorous digital pressure on the fistula., Evaluation of variations in the following symptoms: pain, functional limitation, pruritus, suppuration and bad odor measured by using a visual analogue scale (VAS), throughout follow-up., Changes in health-related quality of life assessed using the Euroqol-5D-3L questionnaire, throughout follow-up., Pro-inflammatory biomarkers: determination of TNFa, IL17a, IL-1a, IL-6, IL1Ra, IL-8 and VEGF, in plasma.
Interventions
DRUGAllogenic adipose-derived adult mesenchymal stem cells expanded
DRUGMixture of: 50% hyaluronic acid
DRUG49% DMEM without phenol red and 1% L-Alanine-L Glutamine
Sponsors
Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAFETY: During the intervention, in the 24 hours afterwards and throughout the 24 months that the follow-up will last, adverse events, serious adverse events related to the investigational drug during the infusion will be evaluated as the main variable., EFFICACY: The combined remission of the treated draining fistula, defined as one that simultaneously meets the 4 criteria: Closure of all draining fistulous orifices present at the time of the inclusion of the patient in the study; Absence of suppuration after the vigorous digital pressure on the fistula; Absence of collections larger than 2 cm in the treated fistula, evaluated by blind ultrasound; And absence of inflammation evaluated by blind doppler ultrasound, in the 2 axes of the lesion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anatomical characteristics of the treated draining fistula: Location (armpits, groin, glutes, genital, perianal, submammary, others); Dimensions; Depth; And inflammatory activity., Clinical remission of the treated draining fistula, defined as the closure of all the draining fistula orifices at the beginning of the trial and absence of suppuration after application of vigorous digital pressure on the fistula., Evaluation of variations in the following symptoms: pain, functional limitation, pruritus, suppuration and bad odor measured by using a visual analogue scale (VAS), throughout follow-up., Changes in health-related quality of life assessed using the Euroqol-5D-3L questionnaire, throughout follow-up., Pro-inflammatory biomarkers: determination of TNFa, IL17a, IL-1a, IL-6, IL1Ra, IL-8 and VEGF, in plasma. | — |
Countries
Spain
Outcome results
None listed