Clinical trial NCT05274295: Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
Official title: Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Leg Ulcer
Autologous Adipose Stromal Vascular Fraction
Mesenchymal Stem Cells
Adipose-Derived Mesenchymal Stem Cells
Keywords: Cytori Celution System
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers.

Detailed description: This motive trial can help to establish rutine application of this internationaly widely used device at University of Szeged. The primary outcome is the reduction rate of the wound size. The treatment response will be calculated from wound size before and after treatment. Any AEs related to the study devide will be monitored.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Males or females age ≥ 18
3. At least one diabetic leg ulcer with the following condition 3.1. Ulcer is present beyond 2 months 3.2. Conservative treatment not leading to improvement 3.3. Wound size between ≥5 and ≤100 cm2
4. Ability to safely undergo tissue harvest that is anticipated to yield \>100mL of adipose tissue at a site that is free from infection and injury
5. Patients diagnosed with diabetes mellitus
6. Able and willing to work with the doctor, adhere to therapeutic prescriptions and appear on prescribed examinations
7. Normal or clinically not significant abnormal values based on investigator judgement on white blood cell count (WBC), C-reactive protein (CRP), Platelets, international normalized ratiod (INR), partial thromboplastin time (APTT), haemoglobin (Hgb), Renal and Liver function
8. Females of childbearing potential must have a negative pregnancy test at the Screen Visit
9. Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which has a proven low failure rate of less than 1%

Exclusion Criteria:

1. More than 20% change in surface area of target ulcer between screening and renrollment visit.
2. There is bone involvement in case of ulcer
3. Patient with a history of bleeding disorder
4. Therapy for anticoagulation
5. Patient receiving corticosteroids, immunosuppressive or cytotoxic agents, and all systemic agents that can affect wound repair
6. Patient with any treatment that might interfere with the assessment of the study treatment
7. Pregnant or likely to become pregnant or lactating women
8. Participation in any type of clinical investigation concurrently or in the last 6 months
9. Positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) and syphilis (results within 1 month are acceptable)
10. Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for the participation in the study.
11. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission had place less than 5 years before joining the study (except basal cell skin cancer)
12. Patient currently undergoing dialysis for renal insufficiency (serum creatinine ≥2 mg/dL)
13. In the opinion of treating physician, patient not expected to survive beyond 30 days
14. Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
15. Uncontrolled chronic disease
16. Patient with history of severe alcohol or drug abuse
17. Lack of patient's cooperation
18. Use with blood thinners within 8 weeks of enrollment, patients treated with Acetylsalicil Acid (ASA) are allowed to be enrolled. For these patients ASA therapy has to be swiched to Low Molecular Weight Heparin (LMWH) at screening (after cardiology consultation) for one week. LMWH has to be skipped on enrollment visit and ASA has to be re-started as soon as possible after lipoaspiration performed.
19. Systemic treatments with a possible effect on ulcers within 4 weeks prior to enrollment with the following exceptions:

    1. Ustekinumab (within 16 weeks prior to enrollment)
    2. Adalimum, infliximab, alefacept (within 8 weeks prior to enrollment)

Primary outcomes:
measure: Reduction rate of the wound size
timeFrame: 28 days
Secondary outcomes:
measure: Wound closure at Day 28
timeFrame: 28 days
measure: Improvement of Quality of Life (QoL) - EQ-5D-5L
timeFrame: 25 days
measure: Improvement Wound pain
timeFrame: 28 days
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged Department of Dermatology and Allergology
Study officials:
affiliation: Szeged University
name: Balázs Bende, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Szeged University
name: Lajos Kemény, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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