Status:
UNKNOWN
Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Tissue Expansion and Skin Regeneration
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Tissue Expansion;
Skin Regeneration;
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief 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 tiss...
Eligibility Criteria
Inclusion
- Age of 18 to 60 years;
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 80 to 600 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Exclusion
- Not fit for soft tissue expansion treatment;
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- Significant renal, cardiovascular, hepatic and psychiatric diseases;
- Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
- BMI \>30;
- History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
- History of allogenic bone marrow transplantation;
- Long history of smoking;
- Evidence of malignant diseases or unwillingness to participate.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01209611
Start Date
September 1 2010
End Date
December 1 2014
Last Update
April 22 2014
Active Locations (1)
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1
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011