Stem Cell Derived Exome for Treatment of Diabetic Foot
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of diabetic foot.
Signed informed consent before recruiting.
Age above 18 years or less than 90 years.
ECOG score < 4
Disqualifiers
Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
Patients have poor compliance.
Trial design
Design model
Single group
Treatments tested in this trial
Skin drug prepared with exome originated from stem cell
DrugSkin drug prepared with exome originated from stem cell will be applied to patient with diabetic foot.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Stem Cell Derived ExomeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of the treatment
Safety will be assessed by recording all types of advise effects upon and after the treatment.
Time frame
Six months2
Efficacy of the treatment
Efficacy will be defined as objective response rate + steady disease rate.
Time frame
Six monthsSecondary outcomes
1
Duration of remission (DOR)
DOR will be defined as the duration of the diabetic foot remission.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: