Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464213
• Other study ID #: HS201901
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Beijing Tongren Hospital
• Contact: Siyang Ni, Doc
• Phone: +(86)-18911810275
• Email: grandnsy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University	Beijing	Beiijng

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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