Hidradenitis SuppurativaPhase 1/2NCT05934825
Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa
A Phase 1/2 study testing Injectable suspension of allogeneic adult mesenchymal stem cells in people with Hidradenitis Suppurativa, run by Andalusian Network for Design and Translation of Advanced Therapies at 1 site in Spain.
Trial summary
Multicenter Phase I/II Clinical Trial to Evaluate Safety and Efficiency of Allogenic Adult Mesenchymal Stem Cell from Adipose Tissue in Patients With Hidradenitis Suppurativa Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Injectable suspension of allogeneic adult mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2022to 26 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de Las Nieves
Granada, 18014
ALEJANDRO MOLINA LEYVA, alejandromolinaleyva@gmail.com
About this study
Official title: 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
Multicenter Phase I/II Clinical Trial to Evaluate Safety and Efficiency of Allogenic Adult Mesenchymal Stem Cell from Adipose Tissue in Patients With Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Injectable suspension of allogeneic adult mesenchymal stem cells, Placebo
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable suspension of allogeneic adult mesenchymal stem cellsBiological
Cell therapy treatment will be administered in a single dose at the beginning of the study. The treatment consists of the administration of a single dose of allogeneic adult mesenchymal stem cells from adipose tissue. The dose is 120 million cells (drug volume: 20 ml, concentrated at 6 million cels/ml).
PlaceboOther
The placebo consists of the administration of the excipient of the suspension without cells. The excipient is a mixture of 50% hyaluronic acid, 49% DMEM without phenol red and 1% L-Alanine-L Glutamine.
| Study group | Role | What they receive |
|---|---|---|
| Injectable suspension of allogeneic adult mesenchymal stem cells | Experimental | Patients will receive an injectable suspension of allogeneic adult mesenchymal stem cells from adipose tissue intralesionally. Receives: Biological: Injectable suspension of allogeneic adult mesenchymal stem cells |
| Placebo | Placebo comparator | Patients will receive the cell-free suspension vehicle: 49% DMEM without phenol red, 1% L-Alanine LGlutamine and 50% hyaluronic acid Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
To determine the safety of intralesional administration of allogeneic mesenchymal cells in draining fistulas in patients with hidradenitis suppurativa
Measured: 24 months
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
To evaluate the efficacy of intralesional administration of human allogeneic mesenchymal cells versus the control group, in terms of combined remission of the draining fistula.
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start26 Oct 2022
- Primary completion26 Oct 2025 (estimated)
- Study completion26 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934825
- Sponsor's protocol ID
- HidraQureS/2020
- Status last verified
- Jul 2023
- First submitted
- 17 Mar 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05934825
- Acronym / sponsor ID
- HidraQureS/2020
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced TherapiesUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 26 Oct 2025 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter Phase I/II Clinical Trial to Evaluate Safety and Efficiency of Allogenic Adult Mesenchymal Stem Cell from Adipose Tissue in Patients With Hidradenitis Suppurativa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectable suspension of allogeneic adult mesenchymal stem cells | Experimental | Biological: Injectable suspension of allogeneic adult mesenchymal stem cellsPatients will receive an injectable suspension of allogeneic adult mesenchymal stem cells from adipose tissue intralesionally. |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive the cell-free suspension vehicle: 49% DMEM without phenol red, 1% L-Alanine LGlutamine and 50% hyaluronic acid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injectable suspension of allogeneic adult mesenchymal stem cellsCell therapy treatment will be administered in a single dose at the beginning of the study. The treatment consists of the administration of a single dose of allogeneic adult mesenchymal stem cells from adipose tissue. The dose is 120 million cells (drug volume: 20 ml, concentrated at 6 million cels/ml). | Biological | Injectable suspension of allogeneic adult mesenchymal stem cells |
| PlaceboThe placebo consists of the administration of the excipient of the suspension without cells. The excipient is a mixture of 50% hyaluronic acid, 49% DMEM without phenol red and 1% L-Alanine-L Glutamine. | Other | Placebo |
Primary outcome
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Time frame: 24 months
To determine the safety of intralesional administration of allogeneic mesenchymal cells in draining fistulas in patients with hidradenitis suppurativa
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
Time frame: 23 months
To evaluate the efficacy of intralesional administration of human allogeneic mesenchymal cells versus the control group, in terms of combined remission of the draining fistula.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Injectable suspension of allogeneic adult mesenchymal stem cells in people with Hidradenitis Suppurativa, run by Andalusian Network for Design and Translation of Advanced Therapies at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María del Mar Macías Sánchez (671 533 802, mmar.macias@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.