Status:
UNKNOWN
Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
Lead Sponsor:
Beijing Tongren Hospital
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is designated to: 1. investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer. 2. learn the primary effectiveness of Hum...
Eligibility Criteria
Inclusion
- Age ≥ 18 and Age ≤ 75
- Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0%
- Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical treatment
- Full understand the informed consent form, and signed it voluntarily
Exclusion
- Pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception
- Be allergic to any component of the drug or showed allergic constitution
- Showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by MRI
- Have malignancy in the ulcer pathology test, or have a history of malignant tumor
- Unable to clean the wounds due to the formation of tract between the ulcer and other condition
- Infected with hepatitis B virus (HBV), hepatitis virus C (HCV), human immunodeficiency virus (HIV), or treponema pallidum
- Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 2.5 times of the normal value, or Cr\>200 μmol/L
- Have a history of apoplexy, unstable angina pectoris, myocardial infarct
- Have a psychiatric history, drug abuse or alcohol abuse history
- Had participated in any other clinical trials in the past 3 months
- Any other circumstances judged by the researchers disqualify the patient to participate in the trial
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04464213
Start Date
November 1 2020
End Date
December 31 2023
Last Update
October 21 2022
Active Locations (1)
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1
National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University
Beijing, Beiijng, China, 100730