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Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

Primary Purpose

Diabetic Foot Ulcer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Single dose experiments
Multi-dose experiments
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Human placental mesenchymal stem cells, Gel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single dose experiments

Multi-dose experiments

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 7, 2020
Last Updated
October 19, 2022
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04464213
Brief Title
Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
Official Title
Phase I Clinical Trials of Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Human placental mesenchymal stem cells, Gel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single dose experiments
Arm Type
Experimental
Arm Title
Multi-dose experiments
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Single dose experiments
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Multi-dose experiments
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of adverse event
Description
The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Time Frame
0 hour - 24 hours
Title
Rate of adverse event
Description
The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Time Frame
0 Day - 7 Days
Secondary Outcome Measure Information:
Title
Rate of serious adverse event
Description
The rate of serious adverse event in 1 hour after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Time Frame
0 hour - 1 hour
Title
Rate of cure rate
Description
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.
Time Frame
0 day - 34 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siyang Ni, Doc
Phone
+(86)-18911810275
Email
grandnsy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Zhao, Doc
Organizational Affiliation
Beijing Tongren Hospital, CMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University
City
Beijing
State/Province
Beiijng
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siyang Ni, Doc
Phone
+（86）-18911810275
Email
grandnsy@163.com

12. IPD Sharing Statement

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Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

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