Clinical trial with adipose tissue stem cells for the treatment of hidradenitis suppurativa.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

11 Nov 2024 → ongoing

Decision date (initial)

2024-11-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516595-15-00

EudraCT number

2020-004753-68

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the safety of intralesional administration of expanded human allogenic mesenchymal cells extracted from adipose tissue in draining fistulas in patients with hidradenitis suppurativa in terms of Adverse Events and Serious Adverse Events related to the investigational drug.

To evaluate the efficacy of intralesional administration of expanded human allogenic mesenchymal cells extracted from adipose tissue, compared to the control group, in terms of combined remission of the draining fistula after 24 weeks from administration.

Secondary objectives 4

1. Evaluate the clinical remission of the treated draining fistula, including the closure of all the draining fistulous orifices at the beginning of the study.
2. Evaluate suppuration, pain, functional limitation, itching and bad smell of the treated draining fistula, by using a visual analog scale (VAS) for each symptom.
3. Analyze the perceived quality of life after treatment compared to the control group, according to the Euroqol-5D scale.
4. Evaluate the pro-inflammatory biomarker profile at the systemic level and determine its relationship and modification with the study intervention.

Conditions and MedDRA coding

Hidradenitis suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Patients who give their informed consent for participation in the clinical trial.
2. Patients of both sexes with a diagnosis of HS at least 6 months before inclusion.
3. Age between 18 and 70 years.
4. 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.
5. Treatment with Adalimumab according to the product specifications for at least 12 weeks.
6. 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.
7. 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.
8. 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.
9. Blood pregnancy test with negative result in the case of patients of childbearing age.
10. 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.
11. Willingness and ability to comply with the visiting schedule, therapeutic plan, clinical analysis and all study procedures.

Exclusion criteria 16

1. Abscess or inflammatory collection > 2 cm adjacent to the fistula to be treated.
2. Previous surgical treatment of the draining fistula.
3. Known history of alcohol abuse in the 6 months prior to study inclusion.
4. Active malignancy or patients with a history of a previous malignant tumor.
5. Presence or recent history of severe, progressive and uncontrolled hepatic, hematological, gastrointestinal, endocrine, lung, cardiac, neurological, psychiatric or skin disease.
6. Congenital or acquired immunodeficiencies.
7. Positive serology for HIV, HCV or HBV.
8. Allergy to any of the components/excipients of the Investigational Product.
9. Major surgery or severe trauma in the previous 6 months.
10. Patients unwilling or unable to comply with study procedures.
11. Anticipation of the need for surgery in the anatomical area for a reason other than hidradenitis suppurativa.
12. Contraindication to the anesthetic procedure.
13. Systemic immunomodulatory biological treatment other than Adalimumab, live vaccines, or any experimental treatment or participation in an interventional study.
14. Contraindication of magnetic resonance imaging with contrast.
15. 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.
16. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. 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 endpoints 5

1. Anatomical characteristics of the treated draining fistula: Location (armpits, groin, glutes, genital, perianal, submammary, others); Dimensions; Depth; And inflammatory activity.
2. 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.
3. 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.
4. Changes in health-related quality of life assessed using the Euroqol-5D-3L questionnaire, throughout follow-up.
5. Pro-inflammatory biomarkers: determination of TNFa, IL17a, IL-1a, IL-6, IL1Ra, IL-8 and VEGF, in plasma.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Edificio S-2, Calle Americo Vespucio Nº 15, Parque Cientifico Y Tecnologico Cartuja 93 Calle Americo Vespucio Nº 15 Parque Cientifico Y Tecnologico Cartuja 93

City

Sevilla

Postcode

41092

Country

Spain

Scientific contact point

Organisation

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

Contact name

Gloria Carmona Sánchez

Public contact point

Organisation

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

Contact name

Blanca Quijano Ruiz

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications