NCT01443689

Brief Summary

Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.

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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2011

Typical duration 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

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

September 27, 2011

Last Update Submit

November 26, 2012

Conditions

Burns

Keywords

Extensive BurnHuman Cord Blood Mononuclear CellsHuman Umbilical Cord Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (3)

  • The ratio of wound contraction and re-epithelialisation

    6 months after treatment

  • Complete healing time for investigated burn area

    6 months after treatment

  • Vancouver Scar Scale

    6 months after treatment

Secondary Outcomes (4)

  • Incidence of infections and bleedings in burn wounds

    6 months after treatment]

  • Engraftment assessment: Vitality of the graft

    6 months after treatment]

  • McGill pain Questionnaire

    6 months after treatment

  • Incidence of Adverse Events and Serious Adverse Events

    6 months after treatment

Study Arms (3)

Group1 :Conventional plus hUCMSCs treatment

EXPERIMENTAL

Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up.

Biological: human umbilical cord mesenchymal stem cells

Group 2: Conventional plus hCBMNCs and hUCMSCs therapy

EXPERIMENTAL

Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up.

Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells

Group 3:Conventional therapy

ACTIVE COMPARATOR

Participants will be given conventional therapy only with a 6 months follow-up.

Drug: Conventional therapy

Interventions

human umbilical cord mesenchymal stem cellsBIOLOGICAL

Participants will be given conventional therapy plus hUCMSCs transplantation.

Group1 :Conventional plus hUCMSCs treatment
human cord blood mononuclear cells and human umbilical cord mesenchymal stem cellsBIOLOGICAL

Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.

Group 2: Conventional plus hCBMNCs and hUCMSCs therapy
Conventional therapyDRUG

Participants will be given conventional therapy only.

Group 3:Conventional therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between age 18- 65 years, both gender.
  • Diagnosed with Acute, Moderate-Severe, full-thickness burn:
  • Burn occurring within the 72 hours prior to administration. TBSA 20-55%, third degree wounds surface area \< 19 % ;
  • Willing to sign the Informed Consent Form.

You may not qualify if:

  • All other burns except thermal origin.
  • Chronically malnourished, poor medical condition or shock
  • Systemic inflammatory response syndrome (SIRS) or septicopyemia
  • Moderate-severe inhalation injury airways to lung
  • HIV+
  • Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
  • Severe pulmonary and hematological disease, malignancy or hypo-immunity.
  • Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
  • Pregnancy or lactation
  • Enrollment in other trials in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Kunmming Medical College

Kunming, Yunnan, 650033, China

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Jinfeng Fu

CONTACT

86-871-5351281ynfjf@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2011

First Posted

September 30, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

CN(1)