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

Medical University of Warsaw

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Foot Ulcer

Treatments: Biological: Application of allogeneic ADSC stem cells in fibrin gel; Procedure: Standard care in diabetic foot ulcer

Study type: Interventional

Funder types: Other

Identifiers

NCT03865394

1ABC Therapy

2016-004109-15 (EudraCT Number)

PL008125 (Other Identifier)

267976/13/NCBR/2015 (Other Grant/Funding Number)

Z4217 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Allogeneic ADSC cells in fibrin solution

Experimental group

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.

Treatment:

Biological: Application of allogeneic ADSC stem cells in fibrin gel

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

Active Comparator group

Description:

Application of fibrin gel to cover wound surface.

Treatment:

Procedure: Standard care in diabetic foot ulcer