Actively Recruiting
A Multi-centre, Randomised, Single-blind Study to Evaluate Safety, Tolerability and Efficacy of a Single Topical Dose of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
Led by Xintela AB · Updated on 2025-05-04
6
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
X
Xintela AB
Lead Sponsor
V
Vinnova
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary effectiveness of XSTEM-VLU, a topical treatment using selected mesenchymal stem cells, in patients with difficult-to-heal venous leg ulcers. This randomized, single-blind Phase I/IIa study compares XSTEM-VLU with a vehicle control alongside standard wound care to explore potential benefits in healing stubborn ulcers. Participants will receive a single topical dose of either XSTEM-VLU or the vehicle CryoStor CS10. After treatment, patients will be followed weekly for 10 weeks to monitor progress and any side effects. At 4 months post-treatment, they will have a final clinic visit to assess overall outcomes and safety. During the study, patients will undergo regular assessments including monitoring for adverse events, vital signs, laboratory tests, physical exams, and ECGs to evaluate safety. Researchers will also measure wound area reduction, wound re-epithelialization, pain levels, and scar formation using specific scales and tools. The total participation period includes weekly follow-ups for 10 weeks and an end-of-study visit at 4 months after treatment.
CONDITIONS
Brief Title
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Male or female aged 18 years or older
- Body mass index (BMI) between 18.5 and 40.0 kg/m2
- Have a lower leg wound caused by venous insufficiency
- Target wound has not healed despite standard care for at least 6 weeks
- Target wound surface area between 2 and 40 cm2
You will not qualify if you...
- Signs or symptoms of significant infection in the target wound needing antimicrobial treatment
- History of autoimmune diseases such as systemic lupus erythematosus, Addison's disease, Crohn's disease, or type I diabetes mellitus
- Blood HbA1C value greater than 52 mmol/mol
- Presence of plaque psoriasis or other skin diseases that could affect study outcomes
- Evidence of arterial insufficiency
- History of any cancer within the past 5 years
- Target wound diagnosed as malignant, neuropathic, pressure wound, or osteomyelitis
- Immunocompromised due to disease or use of systemic immunosuppressants
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From dosing to 4 months after dosing
Participants receive a single topical dose of XSTEM-VLU or placebo to treat venous leg ulcers.
Approximately 6 post-treatment visits
Trial Site Locations
Total: 4 locations
1
Clinical Trial Center (CTC)
Gothenburg, Sweden, SE-413 46
Actively Recruiting
2
Burn Centre, Linköping University Hospital
Linköping, Sweden, SE-581 85
Withdrawn
3
Clinical Research Unit
Lund, Sweden, SE-221 85
Withdrawn
4
Clinical Trial Consultants (CTC) Karolinska
Stockholm, Sweden, SE-171 64
Actively Recruiting
Research Team
C
Central contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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