Umbilical Cord Blood-derived Mesenchymal Stem Cells in Re... | NCT02304562

Studies
Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair

NCT02304562

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Dec 2, 2014Estimated

Enrollment

50Estimated

Phase

Phase 1

Conditions

Sweat Gland Diseases

Interventions

UCB Mesenchymal Stem Cells treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 21, 2014

First Submission Date that Met QC Criteria

Dec 1, 2014

First Posted Date

Dec 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2014

Last Update Posted Date

Dec 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with skin injury treated with Umbilical Cord Blood-derived Mesenchymal Stem Cells,such as deep burn damaged sweat glands,Effectiveness of Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair is determined.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UCB Mesenchymal Stem Cells	Experimental	UCB Mesenchymal Stem Cells treatment of patients with skin injury	Biological: UCB Mesenchymal Stem Cells treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UCB Mesenchymal Stem Cells treatment	Biological	reduce skin injury	UCB Mesenchymal Stem Cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of Adverse Events	Frequency and severity of Adverse Events	6 months

Secondary Outcomes

Measure	Description	Time Frame
Active and inactive lesion count		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Burn area:10-20％TBSA

Exclusion Criteria:

Have influence on the speed of wound healing of patients with chronic diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xiaobing FU	Contact	+86(10)937516

Overall Officials

Name	Affiliation	Role
xiaobing FU	Chinese PLA General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital	Recruiting	Beijing	Beijing Municipality	100039	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17056067	Background	Fu X, Qu Z, Sheng Z. Potentiality of mesenchymal stem cells in regeneration of sweat glands. J Surg Res. 2006 Dec;136(2):204-8. doi: 10.1016/j.jss.2005.03.024. Epub 2006 Oct 20.

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases