Back to resultsA Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
Primary Purpose
Venous Leg Ulcer
Status
Recruiting
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
XSTEM-VLU
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
Eligibility Criteria
Major Inclusion Criteria:
- Written informed consent for participation in the study
- Male or female patient aged ≥18 years
- BMI ≥18.5 and ≥35.0 kg/m2
- Lower leg wound due to venous insufficiency
- Target wound has failed to heal despite standard wound care including compression therapy for a minimum of 6 weeks
- Patient who has been compliant to their prescribed compression therapy over the (at least) 6 weeks prior to screening
- A surface area of the target wound of ≥7 and ≤15 cm2
Major Exclusion Criteria:
- Signs or symptoms of clinically significant ongoing infection requiring intravenous or oral systemic 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
- Concomitant treatment that may interfere with the stem cell treatment
- Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants
Sites / Locations
- Clinical Trial Center (CTC)Recruiting
- Burn Centre, Linköping University HospitalRecruiting
- Clinical Research Unit
- Clinical Trial Consultants (CTC) KarolinskaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XSTEM-VLU
Vehicle
Arm Description
Single topical dose of XSTEM-VLU
Single topical dose of CryoStor CS10
Outcomes
Primary Outcome Measures
Safety and tolerability: Adverse events (AEs)
Frequency, seriousness and intensity of AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
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)
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.
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.
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.
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.
Secondary Outcome Measures
Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline
Preliminary efficacy: Proportion of patients with re-epithelialization of >=95% and >=50% of the wound area measured at baseline
Preliminary efficacy: Time to re-epithelialization of >=95% and >=50% of the wound area measured at baseline
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).
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.
Full Information
NCT ID
NCT05549609
First Posted
September 6, 2022
Last Updated
October 10, 2023
Sponsor
Xintela AB
Collaborators
Vinnova
1. Study Identification
Unique Protocol Identification Number
NCT05549609
Brief Title
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xintela AB
Collaborators
Vinnova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
The patients will be followed weekly for 10 weeks after treatment. At 6 months after treatment, the patients will return to the clinic for an end-of-study visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XSTEM-VLU
Arm Type
Experimental
Arm Description
Single topical dose of XSTEM-VLU
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Single topical dose of CryoStor CS10
Intervention Type
Biological
Intervention Name(s)
XSTEM-VLU
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
CryoStor CS10 cryomedium
Primary Outcome Measure Information:
Title
Safety and tolerability: Adverse events (AEs)
Description
Frequency, seriousness and intensity of AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame
From study start to 6 months after dosing
Title
Safety and tolerability: Local tolerability
Description
Local tolerability evaluated by direct inspection by need for debridement (Yes/No) and clinical signs of wound infection (Yes/No)
Time Frame
From study start to 6 months after dosing
Title
Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG)
Description
Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Time Frame
From study start to 6 months after dosing
Title
Safety and tolerability: Number of participants with abnormal vital signs
Description
Vital signs include blood pressure, pulse and body temperature. Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Time Frame
From study start to 6 months after dosing
Title
Safety and tolerability: Number of participants with abnormal laboratory test results
Description
Laboratory tests include clinical chemistry, haematology and coagulation parameters. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs.
Time Frame
From study start to 6 months after dosing
Title
Safety and tolerability: Number of participants with abnormal physical examination findings
Description
Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Time Frame
From study start to 6 months after dosing
Secondary Outcome Measure Information:
Title
Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline
Time Frame
From study start to 6 months after dosing
Title
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 6 months after dosing
Title
Preliminary efficacy: Time to re-epithelialization of >=95% and >=50% of the wound area measured at baseline
Time Frame
From study start to 6 months after dosing
Title
Preliminary efficacy: Pain for target wound and the affected leg using Visual Analogue Scale (VAS)
Description
The VAS consists of a 100 mm line from no pain (0 mm) to worst possible pain (100 mm).
Time Frame
From study start to 6 months after dosing
Title
Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS)
Description
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.
Time Frame
At week 10 and at 6 months after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria:
Written informed consent for participation in the study
Male or female patient aged ≥18 years
BMI ≥18.5 and ≥35.0 kg/m2
Lower leg wound due to venous insufficiency
Target wound has failed to heal despite standard wound care including compression therapy for a minimum of 6 weeks
Patient who has been compliant to their prescribed compression therapy over the (at least) 6 weeks prior to screening
A surface area of the target wound of ≥3 and ≤40 cm2
Major Exclusion Criteria:
Signs or symptoms of clinically significant ongoing infection requiring intravenous or oral systemic 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
Concomitant treatment that may interfere with the stem cell treatment
Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Central contact
Phone
+46 73 435 53 42
Email
clinicaltrials@xintela.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Folke Sjöberg
Organizational Affiliation
Burn Centre, Linkoping University Hospital, Linkoping, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center (CTC)
City
Gothenburg
ZIP/Postal Code
SE-413 46
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
Phone
+46 31 343 99 19
Email
rekrytering.ctc.su@vgregion.se
First Name & Middle Initial & Last Name & Degree
Rahime Inci, MD
Facility Name
Burn Centre, Linköping University Hospital
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Folke Sjöberg
Email
folke.sjoberg@liu.se
First Name & Middle Initial & Last Name & Degree
Matilda Karlsson
Phone
+46 10 103 19 54
First Name & Middle Initial & Last Name & Degree
Folke Sjöberg, MD, Prof
Facility Name
Clinical Research Unit
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+46 46 17 31 24
Email
Studie201.sus.lund@skane.se
First Name & Middle Initial & Last Name & Degree
Louise Hagman Bennet, MD, Ass. Prof.
Facility Name
Clinical Trial Consultants (CTC) Karolinska
City
Stockholm
ZIP/Postal Code
SE-171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
Phone
+46 18 30 33 99
Email
info@ctc-ab.se
First Name & Middle Initial & Last Name & Degree
Kaveh Azizi, MD
12. IPD Sharing Statement
Learn more about this trial
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
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