Evaluating stem cell treatment for hidradenitis suppurativa
A Multicenter Phase I/II Clinical Trial, Randomized, Double Blind, Controlled With Placebo to Evaluate Safety and Efficiency of Allogenic Adult Mesenchymal Stem Cells From Adipose Tissue in the Treatment of Draining Fistulas in Patients With Hidradenitis Suppurativa
This study is testing whether a new stem cell treatment can help people with hidradenitis suppurativa feel better and improve their symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Andalusian Network for Design and Translation of Advanced Therapies Academic / other |
| Drugs / interventions | Adalimumab |
| Locations | 1 site (Granada) |
| Trial ID | NCT05934825 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of allogenic adult mesenchymal stem cells derived from adipose tissue in patients suffering from hidradenitis suppurativa. It is a multicenter Phase I/II trial that includes patients who have been diagnosed with the condition for at least six months and have specific clinical characteristics. Participants will receive either the stem cell treatment or a placebo, and their responses will be monitored to determine the treatment's efficacy and safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with hidradenitis suppurativa who have been treated with Adalimumab for at least 12 weeks and meet specific clinical criteria.
Not a fit: Patients who do not have active drainage from their hidradenitis suppurativa lesions or those who have not been on Adalimumab for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with hidradenitis suppurativa, potentially improving their quality of life.
How similar studies have performed: While the use of mesenchymal stem cells in treating various conditions has shown promise, this specific application in hidradenitis suppurativa is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who give informed consent for participation in the clinical trial * Diagnosed 6 months before inclusion * Drainage fistula with a minimum of 1 subcutaneous tract and 1 cutaneous drainage orifice evaluated clinically and by cutaneous ultrasound. The fistula must have active drainage 4 weeks prior to inclusion * Treatment with Adalimumab for at least 12 weeks. * Normal renal function or moderate chronic renal insufficiency with creatinine clearance values greater than 60 ml/min or serum creatinine less than 1.5 times the upper limit. * Normal liver function with total bilirubin values less than 1.5 times the upper limit of normal and transaminases \< 2.5 times the upper limit of normal. * Hemogram and coagulation studies within normal values (Leukocytes ≥ 3000, Neutrophils ≥ 1500, Platelets ≥ 100000, hemoglobin\>10g/dl). * Negative blood pregnancy test for patients of childbearing age * Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up. * Willingness and ability to comply with the visit schedule, treatment plan, clinical tests and all study procedures. and all study procedures. Exclusion Criteria: * Poorly controlled HS requiring additional systemic treatment or change of baseline anti-inflammatory therapy * Abscess or inflammatory collection \> 2 cm adjacent to the fistula to be treated. * Previous surgical treatment on the draining fistula * Known history of alcohol abuse in the 6 months prior to study entry * Active malignancy or patients with a history of a previous malignant tumor. * Presence or recent history of severe, progressive and uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric or skin disease * Congenital or acquired immunodeficiencies * Positive serology for HIV, HCV or HBV. * Active COVID-19 infection confirmed by serology and PCR or rapid antigen test * Allergy to any of the components/excipients of the Investigational Product * Major surgery or severe trauma in the previous 6 months * Patients unwilling or unable to comply with study procedures. * Anticipated need for surgery in the anatomical area for a reason other than hidradenitis suppurative * Contraindication to the anesthetic procedure * Systemic immunomodulatory biologic therapy other than Adalimumab, topical or systemic antibiotics for HS, systemic or intralesional corticosteroids, live vaccines, or any experimental treatment or intervention study participation. * Contraindication of nuclear magnetic resonance with contrast. * Women who are pregnant, breastfeeding, or of childbearing age who are not using an effective contraceptive method. * Patients who are currently participating or have completed participation in a clinical trial in a period of less than 3 months or who have participated in an Advanced Therapies clinical trial at any previous time and have been assigned to an experimental group.
Where this trial is running
Granada
- Hospital Universitario Virgen de Las Nieves — Granada, Spain (Recruiting)
Study contacts
- Study coordinator: María del Mar Macías Sánchez
- Email: mmar.macias@juntadeandalucia.es
- Phone: 671 533 802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.