NCT02685722

UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

Umbilical Cord Mesenchymal Stem Cells Between Gel Treatment Difficult Skin Ulcer Healing Efficacy and Safety of Random, Open, Before-and-after Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 17 Years – 78 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-02-19
• Last updated: 2016-02-19

Locations

1 site across 1 country: China