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Completed

NCT Number: NCT02685722

UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

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.

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Key information

Conditions

Difficult to Healing of Skin Ulcers

Age range

17 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese PLA General Hospital

Beijing, 100039, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UC-MSCs Gel group

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

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.

Primary outcomes

  1. Frequency of Adverse Events

    Time frame: 6 months

    Frequency and severity of Adverse Events

Secondary outcomes

  1. Relative Wound Area Regression of 40% or More at 6 Week

    Time frame: 6 week

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Acronym: UC-MSCs

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 19, 2016
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.