search
Back to results

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

Primary Purpose

Diabetic Foot Ulcer, Leg Ulcer, Autologous Adipose Stromal Vascular Fraction

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Diabetic leg ulcer treatment with adipous SVF
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Diabetic Foot Ulcer focused on measuring Cytori Celution System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Szeged Department of Dermatology and AllergologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction rate of the wound size
The treatment response will be calculated from wound size before and after treatment.

Secondary Outcome Measures

Wound closure at Day 28
Percentage of patients achieving 50% wound closure at Day 28
Improvement of Quality of Life (QoL) - EQ-5D-5L
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
Improvement Wound pain visual analogue scale (VAS)

Full Information

First Posted
March 1, 2022
Last Updated
May 2, 2022
Sponsor
Szeged University
search

1. Study Identification

Unique Protocol Identification Number
NCT05274295
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Szeged University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Leg Ulcer, Autologous Adipose Stromal Vascular Fraction, Mesenchymal Stem Cells, Adipose-Derived Mesenchymal Stem Cells
Keywords
Cytori Celution System

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Diabetic leg ulcer treatment with adipous SVF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction rate of the wound size
Description
The treatment response will be calculated from wound size before and after treatment.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Wound closure at Day 28
Description
Percentage of patients achieving 50% wound closure at Day 28
Time Frame
28 days
Title
Improvement of Quality of Life (QoL) - EQ-5D-5L
Description
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.
Time Frame
25 days
Title
Improvement Wound pain
Description
Improvement Wound pain visual analogue scale (VAS)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Balázs Bende
Phone
+36-62-545-277
Email
bende.balazs@szte.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balázs Bende, MD
Organizational Affiliation
Szeged University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lajos Kemény, Prof. Dr.
Organizational Affiliation
Szeged University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Szeged Department of Dermatology and Allergology
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lajos Kemény, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Balázs Bende, MD
First Name & Middle Initial & Last Name & Degree
Lajos Kemény, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Győző Szolnoky, MD PhD
First Name & Middle Initial & Last Name & Degree
Zoltán Veréb, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16923606
Citation
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.
Results Reference
background
PubMed Identifier
17949362
Citation
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.
Results Reference
background
PubMed Identifier
26724220
Citation
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.
Results Reference
background
PubMed Identifier
16236628
Citation
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.
Results Reference
background
PubMed Identifier
26921857
Citation
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.
Results Reference
background
PubMed Identifier
26976717
Citation
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.
Results Reference
background
PubMed Identifier
21431509
Citation
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.
Results Reference
background
PubMed Identifier
12021244
Citation
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.
Results Reference
background
PubMed Identifier
17474297
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs