CClinicalTrials.gg
Status unknownNCT02595047Updated Nov 3, 2015

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

An interventional study of tissue/ organ prefabrication in Soft Tissue Infections and Intentional Self Harm by Other Specified Means, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 5 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-03.

Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
5 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Soft Tissue Infections
  • Intentional Self Harm by Other Specified Means

Keywords

  • Self-regeneration, in vivo tissue prefabrication,
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In context

Soft Tissue Infections

90 studies on the registry are indexed under Soft Tissue Infections; 11 are open to participants now.

This study's planned enrollment of 1 is below the median of 120 across 57 interventional studies indexed under Soft Tissue Infections.

Browse Soft Tissue Infections studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (estimated)

Study arms

  • Experimental
    tissue/ organ prefabrication

    in vivo generation of autologous tissue for joint replacement

    Procedure: tissue/ organ prefabrication

Interventions

  • Proceduretissue/ organ prefabrication

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

    Also known as: ear, joint, bone, cartilage

06

What researchers measure

Primary outcomes

  1. Occurence of major adverse events

    Including infection, necrosis, resorption

    Time frame: through study completion 12 months after prefabrication

Secondary outcomes

  1. Feasibility of self-prefabrication

    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 outcomes

  1. survival of prefabricated tissue after grafting

    Assessed by radiologic imaging (CT, MRT)

    Time frame: 3, 6, 12, and 36 months after grafting

  2. biomechanical function of prefabricated tissue after grafting

    Assessed by total range of motion (degree)

    Time frame: 3, 6, 12, and 36 months after grafting

  3. biomechanical function of prefabricated tissue after grafting

    Assessed by grip strength (kg)

    Time frame: 3, 6, 12, and 36 months after grafting

07

Study locations

1 site
  • Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200011, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02595047
Lead sponsor
Shanghai Jiao Tong University School of Medicine
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, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Nov 3, 2015
Start date
Jan 2013
Primary completion
Jun 2015
Completion
Dec 2016 (estimated)
Last update
Nov 3, 2015

Study contacts

Qingfeng Li, MD,PhD
study director · Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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