Autologous Prefabrication of Body Surface Tissues/ Organs... | NCT02595047

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

NCT02595047

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Nov 3, 2015Estimated

Enrollment

1Estimated

Phase

Not Applicable

Conditions

Soft Tissue Infections
Intentional Self Harm by Other Specified Means

Interventions

tissue/ organ prefabrication

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2015Actual

Completion Date

Dec 2016Estimated

First Submitted Date

Sep 27, 2015

First Submission Date that Met QC Criteria

Oct 30, 2015

First Posted Date

Nov 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2015

Last Update Posted Date

Nov 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tissue/ organ prefabrication	Experimental	in vivo generation of autologous tissue for joint replacement	Procedure: tissue/ organ prefabrication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tissue/ organ prefabrication	Procedure	tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes	tissue/ organ prefabrication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurence of major adverse events	Including infection, necrosis, resorption	through study completion 12 months after prefabrication

Secondary Outcomes

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 Outcomes

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)

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qingfeng Li, MD,PhD	Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine		Shanghai	Shanghai Municipality	200011	China

Type	Date	Date Unknown
Release	Jan 19, 2021
Reset	Feb 8, 2021

Submission Tracking

Estimated Results First Submitted Date

Jan 19, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 19, 2021			Feb 8, 2021

ID	Term
D018461	Soft Tissue Infections

ID	Term
D007239	Infections

Intervention Browse Module

MeSH Terms

ID	Term
D006650	Histocompatibility Testing

Ancestor Terms

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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Browse Branches

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