This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
It is estimated that about 150 million people are suffering diabetes mellitus, of whom more than 15% will develop foot ulcers or gangrene at some times, so called diabetic foot. The diabetic foot is very difficult to cure by traditional approaches. This phase I clinical trial is designed to assess the safety and theraputical benefit of the stem cell derived exome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Skin drug prepared with exome originated from stem cell will be applied to patient with diabetic foot.
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Safety of the treatment
Safety will be assessed by recording all types of advise effects upon and after the treatment.
Time frame: Six months
Efficacy of the treatment
Efficacy will be defined as objective response rate + steady disease rate.
Time frame: Six months
Duration of remission (DOR)
DOR will be defined as the duration of the diabetic foot remission.
Time frame: 5 years
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