Skin Drug Prepared From Stem Cell Derived Exome for Treatment of Diabetic Foot: a Phase II Clinical Trial
Overview
- Phase
- Phase 1
- Intervention
- Skin drug prepared with exome originated from stem cell
- Conditions
- Diabetic Foot
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Safety of the treatment
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of diabetic foot.
- •Signed informed consent before recruiting.
- •Age above 18 years or less than 90 years.
- •ECOG score \< 4
- •Tolerable coagulation function or reversible coagulation disorders
- •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
- •Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Exclusion Criteria
- •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.
- •Allergic to the skin drug;
- •Any agents which could affect the absorption or pharmacokinetics of the study drugs
- •Other conditions that investigator decides not suitable for the trial.
Arms & Interventions
Stem Cell Derived Exome
Intervention: Skin drug prepared with exome originated from stem cell
Outcomes
Primary Outcomes
Safety of the treatment
Time Frame: Six months
Safety will be assessed by recording all types of advise effects upon and after the treatment.
Efficacy of the treatment
Time Frame: Six months
Efficacy will be defined as objective response rate + steady disease rate.
Secondary Outcomes
- Duration of remission (DOR)(5 years)