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

Diabetic Foot Ulcer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865394
• Other study ID #: 1ABC Therapy
• Secondary ID: 267976/13/NCBR/2
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2021
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Biological:
• Application of allogeneic ADSC stem cells in fibrin gel
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.

Procedure:
• Standard care in diabetic foot ulcer
Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control.

Locations

Country	Name	City	State
Poland	Medical University of Warsaw, Department of Diabetology and Internal Diseases	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Polish Stem Cells Bank S.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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).	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	Record of adverse events	Evaluation of the safety of ADSC application, assessed by the occurrence of any adverse events.	8 weeks