Autologous Prefabrication of Body Surface Tissues/ Organs(e.g. Joint)

Shanghai Jiao Tong University School of Medicine1 enrolled

Overview

The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Soft Tissue Infections Intentional Self Harm by Other Specified Means

Interventions

tissue/ organ prefabricationPROCEDURE

tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes

Eligibility

Sex: ALLMin age: 5 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Occurence of major adverse events

Including infection, necrosis, resorption

Time frame: through study completion 12 months after prefabrication

Secondary Outcomes

Feasibility of self-prefabrication

To observe the regeneration changes of prefabricated neo-tissue by histology (staining) and biomechanical analysis (bone density, Young's modulus)

Time frame: 3, 6, and 12 months after prefabrication

Data from ClinicalTrials.gov

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