NCT01209611

Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Tissue Expansion and Skin Regeneration

Phase 1/2 Study of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Soft Tissue Expansion

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluating whether autologous bone marrow mononuclear cells transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.

Detailed description

Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. Although, on some occasions, decelerating the expander inflation process could reduce the incidence of necrosis, this prolonged therapy circle is to be accompanied with increased complications, including infection and expander rupture, as well as the increased economic expenses by the longer hospitalization. This study is to observe the effects of autologous bone marrow mononuclear cell transplantation on accelerating skin regeneration and promoting tissue expansion process. Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into two groups, named as the experimental group and the control group. Patients from the experimental group will have a bone marrow aspiration and intradermal mononuclear cells transplantation. On the other side, Patients from the control group will have saline injection.

Conditions

• Tissue Expansion;
• Skin Regeneration;
• Reconstruction;
• Bone Marrow Mononuclear Cells

Interventions

Type	Name	Description
PROCEDURE	Autologous bone marrow mononuclear cells	Autologous bone marrow-derived mononuclear cells, after isolated by density gradient centrifugation from bone marrow aspiration and resuspended in saline, will be transplanted subcutaneously to expanded skin. The number of infused cells will be 1x10e6/cm2.
PROCEDURE	Placebo	Patients will have mimical bone marrow aspiration under local anesthesia following with saline injection to expanded skin.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• Completion: 2014-12-01
• First posted: 2010-09-27
• Last updated: 2014-04-22

Locations

1 site across 1 country: China