Clinical trial NCT03865394: Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcer
Keywords: stromal vascular fraction
adipose-derived mesenchymal stem cells
chronic wounds
diabetes
foot ulcer
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Polish Stem Cells Bank S.A.
First posted: 2019-03-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in wound size
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in wound morphology
timeFrame: 8 weeks
measure: Changes in pro-angiogenic factors expression
timeFrame: 8 weeks
measure: Changes in wound-associated pain
timeFrame: 8 weeks
measure: Changes in the quality of life
timeFrame: 8 weeks
measure: Record of adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Diabetology and Internal Diseases
Study officials:
affiliation: Medical University of Warsaw, Department of Diabetology and Internal Diseases
name: Beata Mrozikiewicz-Rakowska, . Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References: