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

NCT ID: NCT02595047

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Soft Tissue Infections; Intentional Self Harm by Other Specified Means

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tissue/ organ prefabrication

in vivo generation of autologous tissue for joint replacement

Group Type: EXPERIMENTAL

tissue/ organ prefabrication

Intervention Type: PROCEDURE

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

Interventions

tissue/ organ prefabrication

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

Intervention Type: PROCEDURE

Other Intervention Names

ear, joint, bone, cartilage

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Qing-Feng Li

MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital Affiliation: Shanghai Jiao Tong University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingfeng Li, MD,PhD

Role: STUDY_DIRECTOR

Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

[2012]23

Identifier Type: -

Identifier Source: org_study_id