Umbilical Cord Mesenchymal Stem Cells Between Gel Treatment Difficult Skin Ulcer Healing Efficacy and Safety of Random, Open, Before-and-after Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Frequency of Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 78 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & 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.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: UC-MSCs Gel group (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.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: Gel group (Other)
Outcomes
Primary Outcomes
Frequency of Adverse Events
Time Frame: 6 months
Frequency and severity of Adverse Events
Secondary Outcomes
- Relative Wound Area Regression of 40% or More at 6 Week(6 week)
Investigators
Xiaobing Fu
Principal Investigator
Chinese PLA General Hospital