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

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

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

Study Overview

• Status: Unknown
• Conditions: Soft Tissue Infections; Intentional Self Harm by Other Specified Means
• Intervention / Treatment: Procedure: tissue/ organ prefabrication

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 Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival of prefabricated tissue after grafting	Assessed by radiologic imaging (CT, MRT)	3, 6, 12, and 36 months after grafting
biomechanical function of prefabricated tissue after grafting	Assessed by total range of motion (degree)	3, 6, 12, and 36 months after grafting
biomechanical function of prefabricated tissue after grafting	Assessed by grip strength (kg)	3, 6, 12, and 36 months after grafting

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: Qingfeng Li, MD,PhD, Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: September 27, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Self-regeneration, in vivo tissue prefabrication,
• Additional Relevant MeSH Terms: Behavioral Symptoms; Infections; Soft Tissue Infections; Self-Injurious Behavior
• Other Study ID Numbers: [2012]23