Trials Sponsors Conditions Drugs Pricing

Conditions

Difficult to Healing of Skin Ulcers

Outcome Measures

Primary Outcomes (1)

Frequency of Adverse Events
Frequency and severity of Adverse Events
6 months

Secondary Outcomes (1)

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

Study Arms (2)

UC-MSCs Gel group

EXPERIMENTAL

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

Gel group

EXPERIMENTAL

Interventions

UC-MSCs Gel groupBiological

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.

UC-MSCs Gel group

Gel groupOther

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.

Eligibility Criteria

Age17 Years - 78 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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;

Sponsors & Collaborators

Chinese PLA General Hospital
Otherlead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100039, China

Study Officials

xiaobing Fu
Chinese PLA General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 19, 2016

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

UC-MSCs Gel group

Gel group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

UC-MSCs Gel group

Gel group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations