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

Not Applicable

• Conditions: Intentional Self Harm by Other Specified Means; Soft Tissue Infections
• Interventions: Procedure: tissue/ organ prefabrication

• Registration Number: NCT02595047
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-06
• Study First Submitted: 2015-09-27
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-30
• Last Update Submitted: 2015-10-30
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tissue/ organ prefabrication	tissue/ organ prefabrication	in vivo generation of autologous tissue for joint replacement

Primary Outcome Measures

Name	Time	Method
Occurence of major adverse events	through study completion 12 months after prefabrication	Including infection, necrosis, resorption

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China