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

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

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.

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.

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