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Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells (1ABC)

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Application of allogeneic ADSC stem cells in fibrin gel
Standard care in diabetic foot ulcer
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring stromal vascular fraction, adipose-derived mesenchymal stem cells, chronic wounds, diabetes, foot ulcer

Eligibility Criteria

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

Inclusion Criteria:

  1. Signing informed consent form.
  2. Above the age of 18
  3. Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
  4. Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
  5. Blood level of glycated haemoglobin (HbA1c) <=11%
  6. Satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (>=30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (>=50 mmHg) of the affected limb.
  7. General health condition, which according to the investigator's opinion, allows patient's participation in all study procedures.

Exclusion Criteria:

  1. Lack of patient's cooperation
  2. Wound etiology other than diabetic foot syndrome
  3. Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (<50 mmHg)
  4. Active wound infection, which would require the treatment with antibiotics
  5. Known allergy to ingredients of study product (thrombin, penicillin).
  6. Active venous thromboembolism
  7. Any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study
  8. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study

Sites / Locations

  • Medical University of Warsaw, Department of Diabetology and Internal Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Allogeneic ADSC cells in fibrin solution

Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.

Arm Description

Application of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard procedure of diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface.

Application of fibrin gel to cover wound surface.

Outcomes

Primary Outcome Measures

Changes in wound size
The comparison of the time required for the 50% reduction of initial wound size between patients in both study arms. The wound size changes will be assessed using digital 3D wound imaging medical device with image processing software, according to the following rules: for wounds deeper than 0.5 cm - measurement of wound volume, or for shallow wounds (less than 0.5 cm depth) - measurement of wound surface.

Secondary Outcome Measures

Changes in wound morphology
Clinical assessment of wound morphology (and its changes during the treatment) in each treated patient, as well, as between patients in both study arms, expressed as: the amount (1) and features (2) of wound exudate, the presence of redness (3) and/or edema (4) in the wound surrounding skin, the presence of granular tissue and fibrin (5) or epithelium (6) in the wound bed. The listed parameters will be assessed using simplified questionnaire adopted from Bates-Jensen Wound Assessment Tool (positions 7-13 from B-JWAT). Each of 6 abovementioned features will be assessed semiquantitatively using 1-5 points scale, (with "1" for a best state, and "5" for a worst state). The sum of points allocated to each parameter will be recorded as the wound score and used for further analysis. The healthy skin/healed wound should receive 6 points, whereas active wound, with exudate and inflammation will receive 30 points (the lower = the better / the higher = the worse).
Changes in pro-angiogenic factors expression
Evaluation of the expression (and its changes during the treatment) of selected pro-angiogenic factors, measured in wound biopsies. The changes will be analyzed for each tested individual separately, and compared between both study arms.
Changes in wound-associated pain
Evaluation of the wound-associated pain, assessed by the patient using visual analogue scale. The minimum value is 0 and means "no pain" and the maximum value is 10 and means "the worst possible pain". The lower value the better outcome. The changes will be analyzed for each tested individual separately, and compared between both study arms.
Changes in the quality of life
Evaluation of the patient's quality of life, assessed by the dedicated QoL questionnaire. The QoL questionnaire consists of 10 questions. Each question is scored 1 to 5. The minimum score is 10 and it means "the best possible state of health", and the maximum score is 50, which means ,,the worst possible state of health". The changes will be analyzed for each tested individual separately, and compared between both study arms.
Record of adverse events
Evaluation of the safety of ADSC application, assessed by the occurrence of any adverse events.

Full Information

First Posted
November 8, 2018
Last Updated
October 8, 2021
Sponsor
Medical University of Warsaw
Collaborators
Polish Stem Cells Bank S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03865394
Brief Title
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
Acronym
1ABC
Official Title
Evaluation of the Safety and Efficacy of the Treatment of Chronic Wounds in Diabetic Foot Syndrome With the Use of Allogeneic Stem Cells Isolated From Adipose Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
Collaborators
Polish Stem Cells Bank S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.
Detailed Description
The product will contain an active ingredient- human allogeneic adipose-derived mesenchymal stem cells (ADSC) cells suspended in the fibrin solution applied directly onto prepared wound bed, to form thin gel layer on the wound surface.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
stromal vascular fraction, adipose-derived mesenchymal stem cells, chronic wounds, diabetes, foot ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allogeneic ADSC cells in fibrin solution
Arm Type
Experimental
Arm Description
Application of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard procedure of diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface.
Arm Title
Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.
Arm Type
Active Comparator
Arm Description
Application of fibrin gel to cover wound surface.
Intervention Type
Biological
Intervention Name(s)
Application of allogeneic ADSC stem cells in fibrin gel
Intervention Description
Chronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - single dose will be administered followed by weekly wound control.
Intervention Type
Procedure
Intervention Name(s)
Standard care in diabetic foot ulcer
Intervention Description
Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control.
Primary Outcome Measure Information:
Title
Changes in wound size
Description
The comparison of the time required for the 50% reduction of initial wound size between patients in both study arms. The wound size changes will be assessed using digital 3D wound imaging medical device with image processing software, according to the following rules: for wounds deeper than 0.5 cm - measurement of wound volume, or for shallow wounds (less than 0.5 cm depth) - measurement of wound surface.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in wound morphology
Description
Clinical assessment of wound morphology (and its changes during the treatment) in each treated patient, as well, as between patients in both study arms, expressed as: the amount (1) and features (2) of wound exudate, the presence of redness (3) and/or edema (4) in the wound surrounding skin, the presence of granular tissue and fibrin (5) or epithelium (6) in the wound bed. The listed parameters will be assessed using simplified questionnaire adopted from Bates-Jensen Wound Assessment Tool (positions 7-13 from B-JWAT). Each of 6 abovementioned features will be assessed semiquantitatively using 1-5 points scale, (with "1" for a best state, and "5" for a worst state). The sum of points allocated to each parameter will be recorded as the wound score and used for further analysis. The healthy skin/healed wound should receive 6 points, whereas active wound, with exudate and inflammation will receive 30 points (the lower = the better / the higher = the worse).
Time Frame
8 weeks
Title
Changes in pro-angiogenic factors expression
Description
Evaluation of the expression (and its changes during the treatment) of selected pro-angiogenic factors, measured in wound biopsies. The changes will be analyzed for each tested individual separately, and compared between both study arms.
Time Frame
8 weeks
Title
Changes in wound-associated pain
Description
Evaluation of the wound-associated pain, assessed by the patient using visual analogue scale. The minimum value is 0 and means "no pain" and the maximum value is 10 and means "the worst possible pain". The lower value the better outcome. The changes will be analyzed for each tested individual separately, and compared between both study arms.
Time Frame
8 weeks
Title
Changes in the quality of life
Description
Evaluation of the patient's quality of life, assessed by the dedicated QoL questionnaire. The QoL questionnaire consists of 10 questions. Each question is scored 1 to 5. The minimum score is 10 and it means "the best possible state of health", and the maximum score is 50, which means ,,the worst possible state of health". The changes will be analyzed for each tested individual separately, and compared between both study arms.
Time Frame
8 weeks
Title
Record of adverse events
Description
Evaluation of the safety of ADSC application, assessed by the occurrence of any adverse events.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signing informed consent form. Above the age of 18 Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study Blood level of glycated haemoglobin (HbA1c) <=11% Satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (>=30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (>=50 mmHg) of the affected limb. General health condition, which according to the investigator's opinion, allows patient's participation in all study procedures. Exclusion Criteria: Lack of patient's cooperation Wound etiology other than diabetic foot syndrome Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (<50 mmHg) Active wound infection, which would require the treatment with antibiotics Known allergy to ingredients of study product (thrombin, penicillin). Active venous thromboembolism Any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beata Mrozikiewicz-Rakowska, . Assoc.Prof.
Organizational Affiliation
Medical University of Warsaw, Department of Diabetology and Internal Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Warsaw, Department of Diabetology and Internal Diseases
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells

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