Venous Leg UlcerPhase 1/2NCT05549609
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
A Phase 1/2 study testing XSTEM-VLU in people with Venous Leg Ulcer, run by Xintela AB at 2 sites in Sweden.
Trial summary
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- XSTEM-VLU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 2 sitesSweden
- Study dates
- 26 Oct 2022to 11 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Major Inclusion Criteria:
- Written informed consent for participation in the study
- Male or female patient aged ≥18 years
- BMI ≥18.5 and ≥40.0 kg/m2
- Lower leg wound due to venous insufficiency
- Target wound has failed to heal despite standard wound care for a minimum of 6 weeks
- A surface area of the target wound of ≥2 and ≤40 cm2
Major Exclusion Criteria:
- Signs or symptoms of clinically significant ongoing infection i the target wound requiring anti-microbial treatment
- History of autoimmune disease, such as but not limited to systemic lupus erythematosus, Addison's disease, Crohn's disease and type I diabetes mellitus
- B-HbA1C value ≥52 mmol/mol
- Plaque psoriasis or any other skin disease that could interfere with the outcome of the study
- Arterial insufficiency
- History of any malignancy within the past 5 years
- Target wound diagnosed as a malignant wound, neuropathic wound, pressure wound or osteomyelitis
- Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Clinical Trial Center (CTC)
Gothenburg, SE-413 46
Clinical Trial Consultants (CTC) Karolinska
Stockholm, SE-171 64
About this study
Official title: A Multi-centre, Randomised, Single-blind Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of a Single Topical Dose of Allogeneic Integrin α10β1-selected Mesenchymal Stem Cells (XSTEM-VLU) in Patients With Difficult-to-heal Venous Leg Ulcers
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care.
The patients will be followed weekly for 10 weeks after treatment. At 4 months after treatment, the patients will return to the clinic for an end-of-study visit.
- Conditions
- Venous Leg Ulcer
- Being tested
- XSTEM-VLU, Vehicle
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XSTEM-VLUBiological
XSTEM-VLU is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of venous leg ulcers.
VehicleOther
CryoStor CS10 cryomedium
| Study group | Role | What they receive |
|---|---|---|
| XSTEM-VLU | Experimental | Single topical dose of XSTEM-VLU Receives: Biological: XSTEM-VLU |
| Vehicle | Placebo comparator | Single topical dose of CryoStor CS10 Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Adverse events (AEs)
Frequency, seriousness and intensity of AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: From study start to 4 months after dosing
Safety and tolerability: Local tolerability
Local tolerability evaluated by direct inspection by need for debridement (Yes/No) and clinical signs of wound infection (Yes/No)
Measured: From study start to 4 months after dosing
Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG)
Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Measured: From study start to 4 months after dosing
Safety and tolerability: Number of participants with abnormal vital signs
Vital signs include blood pressure, pulse and body temperature. Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Measured: From study start to 4 months after dosing
Safety and tolerability: Number of participants with abnormal laboratory test results
Laboratory tests include clinical chemistry, haematology and coagulation parameters. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs.
Measured: From study start to 4 months after dosing
Safety and tolerability: Number of participants with abnormal physical examination findings
Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Measured: From study start to 4 months after dosing
Secondary outcomes (5)
Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline
Measured: From study start to 4 months after dosing
Preliminary efficacy: Proportion of patients with re-epithelialization of >=95% and >=50% of the wound area measured at baseline
Measured: From study start to 4 months after dosing
Preliminary efficacy: Time to re-epithelialization of >=95% and >=50% of the wound area measured at baseline
Measured: From study start to 4 months after dosing
Preliminary efficacy: Pain for target wound and the affected leg using Visual Analogue Scale (VAS)
The VAS consists of a 100 mm line from no pain (0 mm) to worst possible pain (100 mm).
Measured: From study start to 4 months after dosing
Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS)
The POSAS is divided into two scales (for patient and for observer), each with six items scored numerically (1 -10). The lowest score "1" corresponds to normal skin.
Measured: At week 10 and at 4 months after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start26 Oct 2022
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xintela AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vinnova
- Responsible party
- Sponsor
- Investigators
- Folke Sjöberg, Principal investigator, Burn Centre, Linkoping University Hospital, Linkoping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549609
- Sponsor's protocol ID
- XIN-XSTEM-201
- Status last verified
- Jun 2026
- First submitted
- 6 Sep 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Single-blind Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of a Single Topical Dose of Allogeneic Integrin α10β1-selected Mesenchymal Stem Cells (XSTEM-VLU) in Patients With Difficult-to-heal Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT05549609
- Acronym / sponsor ID
- XIN-XSTEM-201
- Conditions
- Venous Leg Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Xintela ABIndustry (pharma, biotech, devices)
- Collaborators
- Vinnova
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 22 Sep 2022 (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.
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care.
The patients will be followed weekly for 10 weeks after treatment. At 4 months after treatment, the patients will return to the clinic for an end-of-study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XSTEM-VLU | Experimental | Biological: XSTEM-VLUSingle topical dose of XSTEM-VLU |
| Vehicle | Placebo comparator | Other: VehicleSingle topical dose of CryoStor CS10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| XSTEM-VLUXSTEM-VLU is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of venous leg ulcers. | Biological | XSTEM-VLU |
| VehicleCryoStor CS10 cryomedium | Other | Vehicle |
Primary outcome
Safety and tolerability: Adverse events (AEs)
Time frame: From study start to 4 months after dosing
Frequency, seriousness and intensity of AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Safety and tolerability: Local tolerability
Time frame: From study start to 4 months after dosing
Local tolerability evaluated by direct inspection by need for debridement (Yes/No) and clinical signs of wound infection (Yes/No)
Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG)
Time frame: From study start to 4 months after dosing
Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Safety and tolerability: Number of participants with abnormal vital signs
Time frame: From study start to 4 months after dosing
Vital signs include blood pressure, pulse and body temperature. Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Safety and tolerability: Number of participants with abnormal laboratory test results
Time frame: From study start to 4 months after dosing
Laboratory tests include clinical chemistry, haematology and coagulation parameters. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs.
Safety and tolerability: Number of participants with abnormal physical examination findings
Time frame: From study start to 4 months after dosing
Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
5 secondary outcomes
Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline
Time frame: From study start to 4 months after dosing
Preliminary efficacy: Proportion of patients with re-epithelialization of >=95% and >=50% of the wound area measured at baseline
Time frame: From study start to 4 months after dosing
Preliminary efficacy: Time to re-epithelialization of >=95% and >=50% of the wound area measured at baseline
Time frame: From study start to 4 months after dosing
Preliminary efficacy: Pain for target wound and the affected leg using Visual Analogue Scale (VAS)
Time frame: From study start to 4 months after dosing
Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: At week 10 and at 4 months after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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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.
Folke Sjöberg principal investigator
Burn Centre, Linkoping University Hospital, Linkoping, Sweden
2 sites 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 XSTEM-VLU in people with Venous Leg Ulcer, run by Xintela AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: Adverse events (AEs) (time frame: From study start to 4 months after dosing). The study lists 6 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 26 Jun 2026.