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

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.

Study Overview

• Status: Unknown
• Conditions: Burns
• Intervention / Treatment: Biological: human umbilical cord mesenchymal stem cells; Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells; Drug: Conventional therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650033
      • Recruiting
      • The Second Affiliated Hospital of Kunmming Medical College
      • Contact: Jinfeng Fu; Phone Number: 86-871-5351281; Email: ynfjf@hotmail.com
      • Principal Investigator: Jinfeng Fu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group1 :Conventional plus hUCMSCs treatment; 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; Participants will be given conventional therapy plus hUCMSCs transplantation.
Experimental: Group 2: Conventional plus hCBMNCs and hUCMSCs therapy; 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; Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.
Active Comparator: Group 3:Conventional therapy; Participants will be given conventional therapy only with a 6 months follow-up.	Drug: Conventional therapy; Participants will be given conventional therapy only.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.
• Collaborators: The Second Affiliated Hospital of Kunming Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: September 27, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Estimate): November 28, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Human Umbilical Cord Mesenchymal Stem Cells; Extensive Burn; Human Cord Blood Mononuclear Cells
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: BKCR-BURN-1.0(2011)