Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 1/2
Started
2024-08-01
Last updated
2024-06-28
Condition(s) studied
Diabetic FootStem Cell
Investigational drug(s) / intervention(s)
Skin drug prepared with exome originated from stem cell
Skin drug prepared with exome originated from stem cell: Skin drug prepared with exome originated from stem cell will be applied to patient with diabetic foot.
Study summary
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
1. Clinical diagnosis of diabetic foot.
2. Signed informed consent before recruiting.
3. Age above 18 years or less than 90 years.
4. ECOG score \< 4
5. Tolerable coagulation function or reversible coagulation disorders
6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L; PLT ≥50×10E9/L;INR \< 2.3 or PT \< 6 seconds above control;Cr ≤ 145.5 umul/L;Albumin \> 28 g/L;Total bilirubin \< 51 μmol/L
7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Exclusion Criteria:
1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
4. Patients have poor compliance.
5. Allergic to the skin drug;
6. Any agents which could affect the absorption or pharmacokinetics of the study drugs
7. Other conditions that investigator decides not suitable for the trial.
Primary outcome measure(s)
Safety of the treatment — Six months Safety will be assessed by recording all types of advise effects upon and after the treatment.
Efficacy of the treatment — Six months Efficacy will be defined as objective response rate + steady disease rate.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
More Second Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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