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

Primary Purpose

Difficult to Healing of Skin Ulcers

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UC-MSCs Gel group
Gel group
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Difficult to Healing of Skin Ulcers

Eligibility Criteria

17 Years - 78 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

UC-MSCs Gel group

Gel group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Frequency of Adverse Events
Frequency and severity of Adverse Events

Secondary Outcome Measures

Relative Wound Area Regression of 40% or More at 6 Week

Full Information

First Posted
January 21, 2016
Last Updated
February 18, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02685722
Brief Title
UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers
Acronym
UC-MSCs
Official Title
Umbilical Cord Mesenchymal Stem Cells Between Gel Treatment Difficult Skin Ulcer Healing Efficacy and Safety of Random, Open, Before-and-after Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult to Healing of Skin Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UC-MSCs Gel group
Arm Type
Experimental
Arm Description
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.
Arm Title
Gel group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
UC-MSCs Gel group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gel group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of Adverse Events
Description
Frequency and severity of Adverse Events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Relative Wound Area Regression of 40% or More at 6 Week
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaobing Fu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100039
Country
China

12. IPD Sharing Statement

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UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

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