Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

Overview

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 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.

Full Title of Study: “Phase I Clinical Trials of Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2023

Interventions

  • Other: 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.
  • Other: 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.

Arms, Groups and Cohorts

  • Experimental: Single dose experiments
  • Experimental: Multi-dose experiments

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Rate of serious adverse event
    • Time Frame: 0 hour – 1 hour
    • The rate of serious adverse event in 1 hour after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
  • Rate of cure rate
    • Time Frame: 0 day – 34 days
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Tongren Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xiuli Zhao, Doc, Principal Investigator, Beijing Tongren Hospital, CMU
  • Overall Contact(s)
    • Siyang Ni, Doc, +(86)-18911810275, grandnsy@163.com

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