Evaluation of safety and efficacy of using exosome harvested from human umbilical cord mesenchymal stem cells (hucMSCs) in diabetic foot ulcer patients (Clinical trial Phases I,II)

Qazvin University of Medical Sciences0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

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•Voluntary participation in the research by complying with the requirements of the protocol and accepting the steps related to its implementation and signing the informed consent form
•Age over 30 years and less than 60 years
•Suffering from type I or type II diabetes
•Diabetic foot ulcer size between 1 cm2 to 12 cm2
•Type II or type III wound with Wagner grading and spread to skin, tendon and subcutaneous tissue without evidence of active wound infection at the time of eligibility to participate in the study
•Free of necrotic remnants in the target wound
•Blood glycosylated hemoglobin level (HbA1c) <=10%
•Satisfactory perfusion to the wound as confirmed by measurement of systolic blood pressure in the posterior or anterior tibial artery (>50 mmHg) of the affected limb
•General health status, which according to the researcher, allows the patient to participate in all stages of the study

•1. Non-diabetic pathophysiological wound.
•2. People who need intravenous (IV) antibiotics to treat infection.
•3. Current evidence of infection, including drainage of pus from the wound site.
•4. People with severe kidney failure who cannot be managed with kidney dialysis.
•5. People with severe liver failure.
•6. Human immunodeficiency virus (HIV) positive
•7. People who have an allergic reaction or hypersensitivity to natural proteins and polysaccharides.
•8. Pregnancy or breastfeeding
•9. People with a clinical history related to alcohol or drug abuse.
•10. Suffering from a disease that can affect the study.
•11. People who have had a history of malignant tumor surgery in the last five years (with the exception of carcinoma in situ).
•12. People who are currently enrolled or in another clinical study.
•13. People who have undergone wound treatment with growth factors, skin substitutes or other biological treatments in the last 30 days.
•14. People who receive oral or injectable corticosteroids, immunosuppressant or cytotoxic drugs with unstable dosage before 4 weeks.

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