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

Primary Purpose

Soft Tissue Infections, Intentional Self Harm by Other Specified Means

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tissue/ organ prefabrication
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Infections focused on measuring Self-regeneration, in vivo tissue prefabrication,

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tissue/ organ prefabrication

Arm Description

in vivo generation of autologous tissue for joint replacement

Outcomes

Primary Outcome Measures

Occurence of major adverse events
Including infection, necrosis, resorption

Secondary Outcome Measures

Feasibility of self-prefabrication
To observe the regeneration changes of prefabricated neo-tissue by histology (staining) and biomechanical analysis (bone density, Young's modulus)

Full Information

First Posted
September 27, 2015
Last Updated
October 30, 2015
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02595047
Brief Title
Autologous Prefabrication of Body Surface Tissues/ Organs(e.g. Joint)
Official Title
Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Infections, Intentional Self Harm by Other Specified Means
Keywords
Self-regeneration, in vivo tissue prefabrication,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tissue/ organ prefabrication
Arm Type
Experimental
Arm Description
in vivo generation of autologous tissue for joint replacement
Intervention Type
Procedure
Intervention Name(s)
tissue/ organ prefabrication
Other Intervention Name(s)
ear, joint, bone, cartilage
Intervention Description
tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes
Primary Outcome Measure Information:
Title
Occurence of major adverse events
Description
Including infection, necrosis, resorption
Time Frame
through study completion 12 months after prefabrication
Secondary Outcome Measure Information:
Title
Feasibility of self-prefabrication
Description
To observe the regeneration changes of prefabricated neo-tissue by histology (staining) and biomechanical analysis (bone density, Young's modulus)
Time Frame
3, 6, and 12 months after prefabrication
Other Pre-specified Outcome Measures:
Title
survival of prefabricated tissue after grafting
Description
Assessed by radiologic imaging (CT, MRT)
Time Frame
3, 6, 12, and 36 months after grafting
Title
biomechanical function of prefabricated tissue after grafting
Description
Assessed by total range of motion (degree)
Time Frame
3, 6, 12, and 36 months after grafting
Title
biomechanical function of prefabricated tissue after grafting
Description
Assessed by grip strength (kg)
Time Frame
3, 6, 12, and 36 months after grafting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingfeng Li, MD,PhD
Organizational Affiliation
Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China

12. IPD Sharing Statement

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

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