Allogenic Stem Cell Therapy in Patients With Acute Burn

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01443689
• Other study ID #: BKCR-BURN-1.0(2011)
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 27, 2011
• Last updated: November 26, 2012
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: November 2012
• Source: Shenzhen Beike Bio-Technology Co., Ltd.
• Contact: Jinfeng Fu
• Phone: 86-871-5351281
• Email: ynfjf[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Biological:
• human umbilical cord mesenchymal stem cells
Participants will be given conventional therapy plus hUCMSCs transplantation.
• human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.

Drug:
• Conventional therapy
Participants will be given conventional therapy only.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Kunmming Medical College	Kunming	Yunnan

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Beike Bio-Technology Co., Ltd.	The Second Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of wound contraction and re-epithelialisation		6 months after treatment	No
Primary	Complete healing time for investigated burn area		6 months after treatment	No
Primary	Vancouver Scar Scale		6 months after treatment	No
Secondary	Incidence of infections and bleedings in burn wounds		6 months after treatment]	No
Secondary	Engraftment assessment: Vitality of the graft		6 months after treatment]	No
Secondary	McGill pain Questionnaire		6 months after treatment	No
Secondary	Incidence of Adverse Events and Serious Adverse Events		6 months after treatment	Yes