Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
Study Details
Study Description
Brief Summary
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers On the screening visit, the study physician will assign one eligible ulcer, as the target ulcer. Target ulcer will be treated and followed up during the whole study period. After liposuction investigational device will be applied on the target ulcer. After completion of Day1 visit all subjects enter the observation period and will come back to 3 on-site visits on day 7 day 14 and day 28 |
Device: Diabetic leg ulcer treatment with adipous SVF
The Celution® System isolates approximately maximum 30 million SVF cells per 100 mL of adipose tissue to be processed. Approximately 1-3 million cells per injection (total 8-30) will be administered locally, in the target ulcer.
|
Outcome Measures
Primary Outcome Measures
- Reduction rate of the wound size [28 days]
The treatment response will be calculated from wound size before and after treatment.
Secondary Outcome Measures
- Wound closure at Day 28 [28 days]
Percentage of patients achieving 50% wound closure at Day 28
- Improvement of Quality of Life (QoL) - EQ-5D-5L [25 days]
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
- Improvement Wound pain [28 days]
Improvement Wound pain visual analogue scale (VAS)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent
-
Males or females age ≥ 18
-
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
-
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
-
Patients diagnosed with diabetes mellitus
-
Able and willing to work with the doctor, adhere to therapeutic prescriptions and appear on prescribed examinations
-
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
-
Females of childbearing potential must have a negative pregnancy test at the Screen Visit
-
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:
-
More than 20% change in surface area of target ulcer between screening and renrollment visit.
-
There is bone involvement in case of ulcer
-
Patient with a history of bleeding disorder
-
Therapy for anticoagulation
-
Patient receiving corticosteroids, immunosuppressive or cytotoxic agents, and all systemic agents that can affect wound repair
-
Patient with any treatment that might interfere with the assessment of the study treatment
-
Pregnant or likely to become pregnant or lactating women
-
Participation in any type of clinical investigation concurrently or in the last 6 months
-
Positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) and syphilis (results within 1 month are acceptable)
-
Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for the participation in the study.
-
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)
-
Patient currently undergoing dialysis for renal insufficiency (serum creatinine ≥2 mg/dL)
-
In the opinion of treating physician, patient not expected to survive beyond 30 days
-
Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
-
Uncontrolled chronic disease
-
Patient with history of severe alcohol or drug abuse
-
Lack of patient's cooperation
-
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.
-
Systemic treatments with a possible effect on ulcers within 4 weeks prior to enrollment with the following exceptions:
-
Ustekinumab (within 16 weeks prior to enrollment)
-
Adalimum, infliximab, alefacept (within 8 weeks prior to enrollment)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Szeged Department of Dermatology and Allergology | Szeged | Hungary | 6720 |
Sponsors and Collaborators
- Szeged University
Investigators
- Principal Investigator: Balázs Bende, MD, Szeged University
- Principal Investigator: Lajos Kemény, Prof. Dr., Szeged University
Study Documents (Full-Text)
None provided.More Information
Publications
- Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7.
- Galipeau J, Krampera M, Barrett J, Dazzi F, Deans RJ, DeBruijn J, Dominici M, Fibbe WE, Gee AP, Gimble JM, Hematti P, Koh MB, LeBlanc K, Martin I, McNiece IK, Mendicino M, Oh S, Ortiz L, Phinney DG, Planat V, Shi Y, Stroncek DF, Viswanathan S, Weiss DJ, Sensebe L. International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials. Cytotherapy. 2016 Feb;18(2):151-9. doi: 10.1016/j.jcyt.2015.11.008. Epub 2015 Dec 23.
- Horwitz EM, Le Blanc K, Dominici M, Mueller I, Slaper-Cortenbach I, Marini FC, Deans RJ, Krause DS, Keating A; International Society for Cellular Therapy. Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement. Cytotherapy. 2005;7(5):393-5.
- Le Blanc K, Ringdén O. Immunomodulation by mesenchymal stem cells and clinical experience. J Intern Med. 2007 Nov;262(5):509-25. Review.
- Meng X, Sun B, Xue M, Xu P, Hu F, Xiao Z. Comparative analysis of microRNA expression in human mesenchymal stem cells from umbilical cord and cord blood. Genomics. 2016 Apr;107(4):124-31. doi: 10.1016/j.ygeno.2016.02.006. Epub 2016 Feb 26.
- Schwartz RE, Reyes M, Koodie L, Jiang Y, Blackstad M, Lund T, Lenvik T, Johnson S, Hu WS, Verfaillie CM. Multipotent adult progenitor cells from bone marrow differentiate into functional hepatocyte-like cells. J Clin Invest. 2002 May;109(10):1291-302.
- Tang Y, Yasuhara T, Hara K, Matsukawa N, Maki M, Yu G, Xu L, Hess DC, Borlongan CV. Transplantation of bone marrow-derived stem cells: a promising therapy for stroke. Cell Transplant. 2007;16(2):159-69. Review.
- Volz AC, Huber B, Kluger PJ. Adipose-derived stem cell differentiation as a basic tool for vascularized adipose tissue engineering. Differentiation. 2016 Jul-Aug;92(1-2):52-64. doi: 10.1016/j.diff.2016.02.003. Epub 2016 Mar 11. Review.
- Zachar V, Rasmussen JG, Fink T. Isolation and growth of adipose tissue-derived stem cells. Methods Mol Biol. 2011;698:37-49. doi: 10.1007/978-1-60761-999-4_4.
- SZTE-CCS-DLU-01