Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers

NCT05274295 | Unknown

• 1 other identifier: SZTE-CCS-DLU-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot Ulcer; Leg Ulcer; Autologous Adipose Stromal Vascular Fraction; Mesenchymal Stem Cells; Adipose-Derived Mesenchymal Stem Cells

Keywords

Cytori Celution System

Outcome Measures

Primary Outcomes (1)

• Reduction rate of the wound size

  The treatment response will be calculated from wound size before and after treatment.

  28 days

Secondary Outcomes (3)

• Wound closure at Day 28

  28 days

• Improvement of Quality of Life (QoL) - EQ-5D-5L

  25 days

• Improvement Wound pain

  28 days

Study Arms (1)

Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers

EXPERIMENTAL

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

Interventions

Diabetic leg ulcer treatment with adipous SVF DEVICE

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.

Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

University of Szeged Department of Dermatology and Allergology

Szeged, 6720, Hungary

RECRUITING

Related Publications (9)

• 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.

  PMID: 16923606 BACKGROUND

• 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.

  PMID: 17949362 BACKGROUND

• 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.

  PMID: 26724220 BACKGROUND

• 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.

  PMID: 16236628 BACKGROUND

• 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.

  PMID: 26921857 BACKGROUND

• 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.

  PMID: 26976717 BACKGROUND

• 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.

  PMID: 21431509 BACKGROUND

• 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.

  PMID: 12021244 BACKGROUND

• 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.

  PMID: 17474297 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Leg Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Balázs Bende, MD

  Szeged University

  PRINCIPAL INVESTIGATOR

• Lajos Kemény, Prof. Dr.

  Szeged University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Balázs Bende

CONTACT

+36-62-545-277; bende.balazs@szte.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: February 28, 2022
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)