Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

Study Overview
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Brief Summary
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This study is designated to: investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer. learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.

Official Title
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Phase I Clinical Trials of Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Other: Single dose experiments
* Other: Multi-dose experiments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose experiments<br> | Other: Single dose experiments<br>* In single dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient only receive treatment once time.<br>|
| Experimental: Multi-dose experiments<br> | Other: Multi-dose experiments<br>* In multi-dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient receive treatment on six consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse event | The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. | 0 hour - 24 hours | 
| Rate of adverse event | The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. | 0 Day - 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of serious adverse event | The rate of serious adverse event in 1 hour after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. | 0 hour - 1 hour | 
| Rate of cure rate | Rate of cure rate in 20 days and 34 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. | 0 day - 34 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human placental mesenchymal stem cells, Gel