Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2024-08-01
2033-12-30
Brief Summary
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Detailed Description
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This phase I clinical trial is designed to assess the safety and theraputical benefit of the stem cell derived exome.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stem Cell Derived Exome
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Zhenfeng Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Guangzhou Medical University
Locations
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The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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ZZ-SC-EXOME-DF 026
Identifier Type: -
Identifier Source: org_study_id