Autologous Prefabrication of Body Surface Tissues/ Organs(e.g. Joint)
This trial is active, not recruiting.
|Conditions||soft tissue infections, intentional self harm by other specified means|
|Treatment||tissue/ organ prefabrication|
|Sponsor||Shanghai Jiao Tong University School of Medicine|
|Start date||January 2013|
|End date||June 2015|
|Trial size||1 participant|
|Trial identifier||NCT02595047, 23|
The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||single group assignment|
in vivo generation of autologous tissue for joint replacement
Occurence of major adverse events
time frame: through study completion 12 months after prefabrication
Feasibility of self-prefabrication
time frame: 3, 6, and 12 months after prefabrication
Male or female participants from 5 years up to 65 years old.
Inclusion Criteria: - With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction. Exclusion Criteria: - evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration - 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; - Evidence of malignant diseases - unwillingness to participate.
|Official title||Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction|
|Description||In the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. These uncertainties have hampered road to the clinical application. As the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.|
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