Allogenic Stem Cell Therapy in Patients With Acute Burn

A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Acute Burn

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01443689

Enrollment

Registered

2011-09-30

Start date

2011-07-31

Completion date

2013-07-31

Last updated

2012-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

Extensive Burn, Human Cord Blood Mononuclear Cells, Human Umbilical Cord Mesenchymal Stem Cells

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.

Detailed description

To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Acute, Moderate-Severe, Full-thickness burn.

Interventions

BIOLOGICALhuman umbilical cord mesenchymal stem cells

Participants will be given conventional therapy plus hUCMSCs transplantation.

BIOLOGICALhuman cord blood mononuclear cells and human umbilical cord mesenchymal stem cells

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

DRUGConventional therapy

Participants will be given conventional therapy only.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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. * Other criteria the investigator consider improper for inclusion.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Incidence of infections and bleedings in burn wounds	6 months after treatment]
Incidence of Adverse Events and Serious Adverse Events	6 months after treatment
Engraftment assessment: Vitality of the graft	6 months after treatment]
McGill pain Questionnaire	6 months after treatment

Countries

China

Contacts

Primary ContactJinfeng Fu

ynfjf@hotmail.com86-871-5351281

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026