UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

Chinese PLA General Hospital (301 Hospital)

Status and phase: Completed; Phase 1

Conditions: Difficult to Healing of Skin Ulcers

Treatments: Biological: UC-MSCs Gel group; Other: Gel group

Study type: Interventional

Funder types: Other

Identifiers

NCT02685722

CHIN-PLAGH-ST-008

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 17 to 78 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

UC-MSCs Gel group

Experimental group

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.

Treatment:

Biological: UC-MSCs Gel group

Gel group

Experimental group

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.

Treatment:

Other: Gel group