Status:
COMPLETED
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Polish Stem Cells Bank S.A.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03865394
Start Date
July 1 2019
End Date
September 30 2021
Last Update
October 14 2021
Active Locations (1)
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1
Medical University of Warsaw, Department of Diabetology and Internal Diseases
Warsaw, Poland