NCT02304562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

4.9 years

First QC Date

November 21, 2014

Last Update Submit

December 1, 2014

Conditions

Sweat Gland Diseases

Outcome Measures

Primary Outcomes (1)

  • Frequency of Adverse Events

    Frequency and severity of Adverse Events

    6 months

Secondary Outcomes (1)

  • Active and inactive lesion count

    6 months

Study Arms (1)

UCB Mesenchymal Stem Cells

EXPERIMENTAL

UCB Mesenchymal Stem Cells treatment of patients with skin injury

Biological: UCB Mesenchymal Stem Cells treatment

Interventions

UCB Mesenchymal Stem Cells treatmentBIOLOGICAL

reduce skin injury

UCB Mesenchymal Stem Cells

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Burn area:10-20％TBSA

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 17056067BACKGROUND

MeSH Terms

Conditions

Sweat Gland Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • xiaobing FU

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaobing FU

CONTACT

+86(10)937516

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academician

Study Record Dates

First Submitted

November 21, 2014

First Posted

December 2, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

CN(1)