Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
NCT ID: NCT05274295
Last Updated: 2022-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
5 participants
INTERVENTIONAL
2022-02-28
2022-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Chronic Non-Healing Venous Leg Ulcers
NCT05165459
Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
NCT02987101
A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers
NCT02799121
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
NCT03865394
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
NCT03626623
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Szeged University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Balázs Bende, MD
Role: PRINCIPAL_INVESTIGATOR
Szeged University
Lajos Kemény, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Szeged University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Szeged Department of Dermatology and Allergology
Szeged, , Hungary
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lajos Kemény, Prof. Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1080/14653240600855905.
Le Blanc K, Ringden O. Immunomodulation by mesenchymal stem cells and clinical experience. J Intern Med. 2007 Nov;262(5):509-25. doi: 10.1111/j.1365-2796.2007.01844.x.
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. doi: 10.1080/14653240500319234.
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.
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.
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.
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. doi: 10.1172/JCI15182.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SZTE-CCS-DLU-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.