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

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

Detailed Description
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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.

Official Title
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Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction

Conditions
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Soft Tissue Infections, Intentional Self Harm by Other Specified Means

Intervention / Treatment
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* Procedure: tissue/ organ prefabrication


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tissue/ organ prefabrication<br>in vivo generation of autologous tissue for joint replacement | Procedure: tissue/ organ prefabrication<br>* tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes<br>* Other names: ear, joint, bone, cartilage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of major adverse events | Including infection, necrosis, resorption | through study completion 12 months after prefabrication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of self-prefabrication | To observe the regeneration changes of prefabricated neo-tissue by histology (staining) and biomechanical analysis (bone density, Young's modulus) | 3, 6, and 12 months after prefabrication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-regeneration, in vivo tissue prefabrication,