Stem Cell Derived Exome for Treatment of Diabetic Foot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skin drug prepared with exome originated from stem cell.
- Who it may be relevant to
- Registry conditions: Diabetic Foot, Stem Cell. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Skin Drug Prepared From Stem Cell Derived Exome for Treatment of Diabetic Foot: a Phase II Clinical Trial
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Safety of the treatment [Time frame: Six months]
- Efficacy of the treatment [Time frame: Six months]
Secondary outcome measures (1)
- Duration of remission (DOR) [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT06480123 · ZZ-SC-EXOME-DF 026