UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

Difficult to Healing of Skin Ulcers Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685722
• Other study ID #: CHIN-PLAGH-ST-008
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2016
• Last updated: February 18, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 78 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Difficult to Healing of Skin Ulcers
• Skin Ulcer
• Ulcer

Intervention

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.

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events	Frequency and severity of Adverse Events	6 months	Yes
Secondary	Relative Wound Area Regression of 40% or More at 6 Week		6 week	Yes