Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Other: Single dose experiments; Other: Multi-dose experiments

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Siyang Ni, Doc; Phone Number: +（86）-18911810275; Email: grandnsy@163.com

Study Locations

• China
  • Beiijng
    • Beijing, Beiijng, China, 100730
      • Recruiting
      • National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University
      • Contact: Siyang Ni, Doc; Phone Number: +（86）-18911810275; Email: grandnsy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose experiments	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.
Experimental: Multi-dose experiments	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Xiuli Zhao, Doc, Beijing Tongren Hospital, CMU

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Gel; Human placental mesenchymal stem cells
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: HS201901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No