ALLOGENEIC ADIPOSE-DERIVED ADULT MESENCHYMAL STEM CELLS EXPANDED for Hidradenitis suppurativa

Inclusion criteria

• {"criterion_text":"- Patients who give their informed consent for participation in the clinical trial."}
• {"criterion_text":"- Acceptance by the patient (both men and women), of childbearing potential, to use safe contraceptive methods throughout the study, including the six-month follow-up."}
• {"criterion_text":"- Willingness and ability to comply with the visiting schedule, therapeutic plan, clinical analysis and all study procedures."}
• {"criterion_text":"- Patients of both sexes with a diagnosis of HS at least 6 months before inclusion."}
• {"criterion_text":"- Age between 18 and 70 years."}
• {"criterion_text":"- Draining fistula with a minimum of 1 subcutaneous tract and 1 cutaneous drainage hole evaluated clinically and by skin ultrasound. The fistula must have active drainage 4 weeks before inclusion."}
• {"criterion_text":"- Treatment with Adalimumab according to the product specifications for at least 12 weeks."}
• {"criterion_text":"- Normal kidney function or moderate chronic renal failure with creatinine clearance values higher than 60 ml/min or serum creatinine less than 1.5 times the upper normal limit."}
• {"criterion_text":"- Normal liver function with total bilirubin values less than 1.5 times the upper normal limit and transaminases < 2.5 times the upper normal limit."}
• {"criterion_text":"- Blood count and coagulation study within normal values, defined by: Leukocytes ≥ 3000, Neutrophils ≥ 1500, Platelets ≥ 100000, Hemoglobin>10g/dl and TPr or INR < 1.5 and TTPAr < 1.3, as long as the patient's platelet count is above 50,000/mm3."}
• {"criterion_text":"- Blood pregnancy test with negative result in the case of patients of childbearing age."}

Exclusion criteria

• {"criterion_text":"- Abscess or inflammatory collection > 2 cm adjacent to the fistula to be treated."}
• {"criterion_text":"- Patients unwilling or unable to comply with study procedures."}
• {"criterion_text":"- Anticipation of the need for surgery in the anatomical area for a reason other than hidradenitis suppurativa."}
• {"criterion_text":"- Contraindication to the anesthetic procedure."}
• {"criterion_text":"- Systemic immunomodulatory biological treatment other than Adalimumab, live vaccines, or any experimental treatment or participation in an interventional study."}
• {"criterion_text":"- Contraindication of magnetic resonance imaging with contrast."}
• {"criterion_text":"- Women who are pregnant, breast-feeding, or of childbearing age who are not using an effective method of contraception. A woman of fertile age is considered to be all women from the age 18 and up to one year after the last menstruation in the case of menopausal women."}
• {"criterion_text":"- Patients who are currently participating or have completed their participation in a clinical trial in a period of less than 3 months or who have participated in a clinical trial of Advanced Therapies (cell therapy, gene therapy or tissue engineering) at any previous time and have been assigned to experimental group."}
• {"criterion_text":"- Previous surgical treatment of the draining fistula."}
• {"criterion_text":"- Known history of alcohol abuse in the 6 months prior to study inclusion."}
• {"criterion_text":"- Active malignancy or patients with a history of a previous malignant tumor."}
• {"criterion_text":"- Presence or recent history of severe, progressive and uncontrolled hepatic, hematological, gastrointestinal, endocrine, lung, cardiac, neurological, psychiatric or skin disease."}
• {"criterion_text":"- Congenital or acquired immunodeficiencies."}
• {"criterion_text":"- Positive serology for HIV, HCV or HBV."}
• {"criterion_text":"- Allergy to any of the components/excipients of the Investigational Product."}
• {"criterion_text":"- Major surgery or severe trauma in the previous 6 months."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Adverse events and serious adverse events related to the investigational drug will be recorded during the intervention, in the 24 hours after the intervention and throughout a 24-month follow-up period; monitored and reported as safety outcomes."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Combined remission is assessed at 24 weeks post-administration and requires simultaneous fulfillment of four criteria: closure of all draining orifices, absence of suppuration on vigorous digital pressure, no collections >2 cm on blinded ultrasound, and absence of inflammation on blinded Doppler ultrasound in two axes."}

Secondary endpoints

• {"endpoint_text":"- Anatomical characteristics of the treated draining fistula: Location (armpits, groin, glutes, genital, perianal, submammary, others); Dimensions; Depth; And inflammatory activity.","definition_or_measurement_approach":"Assessed by clinical evaluation and imaging (ultrasound) to document location, dimensions, depth and inflammatory activity."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Clinical assessment of closure of draining orifices and absence of suppuration on digital pressure."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient-reported symptom scores recorded on VAS at specified follow-up visits."}
• {"endpoint_text":"- Changes in health-related quality of life assessed using the Euroqol-5D-3L questionnaire, throughout follow-up.","definition_or_measurement_approach":"EuroQol-5D-3L questionnaire administered at baseline and follow-up visits to measure changes in HRQoL."}
• {"endpoint_text":"- Pro-inflammatory biomarkers: determination of TNFa, IL17a, IL-1a, IL-6, IL1Ra, IL-8 and VEGF, in plasma.","definition_or_measurement_approach":"Laboratory measurement of listed cytokines in plasma samples at specified timepoints."}

Spain

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain