A Phase 1 interventional study of UC-MSCs Gel group and Gel group in Difficult to Healing of Skin Ulcers, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 17 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by Chinese PLA General Hospital · Phase 1, Interventional, and Treatment
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.
79 studies on the registry are indexed under Skin Ulcer; 14 are open to participants now.
This study's enrollment of 20 is below the median of 44 across 65 interventional studies indexed under Skin Ulcer.
Browse Skin Ulcer studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
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.
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.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.
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,Observation of UC-MSCs Gel group patients efficacy, safety and tolerability of selective parameter.
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.
Frequency of Adverse Events
Frequency and severity of Adverse Events
Time frame: 6 months
Relative Wound Area Regression of 40% or More at 6 Week
Time frame: 6 week
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital