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

NCT02595047 | Unknown

• 1 other identifier: [2012]23
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Soft Tissue Infections; Intentional Self Harm by Other Specified Means

Keywords

Self-regeneration, in vivo tissue prefabrication,

Outcome Measures

Primary Outcomes (1)

• Occurence of major adverse events

  Including infection, necrosis, resorption

  through study completion 12 months after prefabrication

Secondary Outcomes (1)

• Feasibility of self-prefabrication

  3, 6, and 12 months after prefabrication

Other Outcomes (3)

• survival of prefabricated tissue after grafting

  3, 6, 12, and 36 months after grafting

• biomechanical function of prefabricated tissue after grafting

  3, 6, 12, and 36 months after grafting

• biomechanical function of prefabricated tissue after grafting

  3, 6, 12, and 36 months after grafting

Study Arms (1)

tissue/ organ prefabrication

EXPERIMENTAL

in vivo generation of autologous tissue for joint replacement

Procedure: tissue/ organ prefabrication

Interventions

tissue/ organ prefabrication PROCEDURE

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

Also known as: ear, joint, bone, cartilage

tissue/ organ prefabrication

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Soft Tissue Infections

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Qingfeng Li, MD,PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital Affiliation: Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: September 27, 2015
• First Posted: November 3, 2015
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 3, 2015

Record last verified: 2015-10

Locations

CN (1)