Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
NCT ID: NCT04464213
Last Updated: 2022-10-21
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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UNKNOWN
PHASE1
43 participants
INTERVENTIONAL
2020-11-01
2023-12-31
Brief Summary
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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 Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
3. study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single dose experiments
Single dose experiments
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.
Multi-dose experiments
Multi-dose experiments
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.
Interventions
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Single dose experiments
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.
Multi-dose experiments
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiuli Zhao, Doc
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital, CMU
Locations
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National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University
Beijing, Beiijng, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS201901
Identifier Type: -
Identifier Source: org_study_id
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