Bone Marrow Mononuclear Cells Clinical Trial
Official title:
Phase 1/2 Study of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Soft Tissue Expansion
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.
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.
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