UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers (UC-MSCs)

Umbilical Cord Mesenchymal Stem Cells Between Gel Treatment Difficult Skin Ulcer Healing Efficacy and Safety of Random, Open, Before-and-after Study

This study for a six-month trials, Randomized, open, and parallel comparison before and after its own, Stage test includes screening stage, treatment period and follow-up period. In accordance with chronic wound criteria for the patient, By producing the principle of random number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according to the situation of wound healing time and decided to use the secondary treatment, To observe the clinical efficacy and safety.

Study Overview

• Status: Completed
• Conditions: Difficult to Healing of Skin Ulcers
• Intervention / Treatment: Biological: UC-MSCs Gel group; Other: Gel group

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100039
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Older than 17 year old male or female (pregnancy);
• Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years of age must be signed by the guardian informed consent;
• The process of psychological stability, can finish the tes

Exclusion Criteria:

• Allergic constitution, or known allergic to pork or beef source products, gao min physique person;
• The wound is more than 10 cm by 10 cm;
• People with mental illness, drug abusers and or other items;
• 1 month used or are using the sugar metabolism of drugs, such as corticosteroids, thiazide diuretics, tricyclic antidepressants, etc;
• 3 month participated in other similar test;
• Serious infectious disease not controller;
• With surgery, such as severe trauma stress situation;
• Always had a history of tumor;
• Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UC-MSCs Gel group; This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.treatment period and follow-up period.In accordance with chronic wound criteria for the patient,By producing the principle of random number,Were randomly divided into UC-MSCs Gel group or Gel group,The researchers according to the situation of wound healing time and decided to use the secondary treatment,to observe the clinical efficacy and safety.	Biological: UC-MSCs Gel group; This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.By generating a random number of principle,Observation of UC-MSCs Gel group patients efficacy, safety and tolerability of selective parameter.
Experimental: Gel group; This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.treatment period and follow-up period.In accordance with chronic wound criteria for the patient,By producing the principle of random number,Were randomly divided into UC-MSCs Gel group or Gel group,The researchers according to the situation of wound healing time and decided to use the secondary treatment,to observe the clinical efficacy and safety.	Other: Gel group; This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.By generating a random number of principle,observed and compared Gel group patients may be no efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events	Frequency and severity of Adverse Events	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Relative Wound Area Regression of 40% or More at 6 Week	6 week

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Ulcer; Skin Ulcer
• Other Study ID Numbers: CHIN-PLAGH-ST-008