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UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers (UC-MSCs)

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ClinicalTrials.gov Identifier: NCT02685722
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaobing Fu, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Difficult to Healing of Skin Ulcers Biological: UC-MSCs Gel group Other: Gel group Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umbilical Cord Mesenchymal Stem Cells Between Gel Treatment Difficult Skin Ulcer Healing Efficacy and Safety of Random, Open, Before-and-after Study
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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,observed and compared Gel group patients may be no efficacy.




Primary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: 6 months ]
    Frequency and severity of Adverse Events


Secondary Outcome Measures :
  1. Relative Wound Area Regression of 40% or More at 6 Week [ Time Frame: 6 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 78 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685722


Locations
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China
Chinese PLA General Hospital
Beijing, China, 100039
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: xiaobing Fu Chinese PLA General Hospital

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Responsible Party: Xiaobing Fu, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02685722     History of Changes
Other Study ID Numbers: CHIN-PLAGH-ST-008
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Skin Ulcer
Ulcer
Pathologic Processes
Skin Diseases