UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

NCT ID: NCT02685722

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Difficult to Healing of Skin Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

UC-MSCs Gel group

Intervention Type: BIOLOGICAL

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.

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.

Group Type: EXPERIMENTAL

Gel group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaobing Fu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xiaobing Fu

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, , China

Countries

China

Other Identifiers

CHIN-PLAGH-ST-008

Identifier Type: -

Identifier Source: org_study_id