Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies

November 18, 2010 updated by: Taipei Medical University WanFang Hospital
Platelet-rich plasma (PRP) has mixed growth factors such as TGF-ß1 and TGF-ß2, vascular epithelial growth factor (VEGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF). These growth factors appear to play an important role in wound healing and are assumed as promoters of tissue regeneration. Moreover, PRP was used as injectable scaffold seeded with chondrocytes to regenerate cartilage. In their previous study, the investigators concluded that growth factors in PRP can effectively react as a growth factor cocktail to induce human nucleus pulposus proliferation and differentiation, and also promote tissue-engineered nucleus pulposus formation. The investigators also have a hypothesis that PRP can promote tissue-engineered microtia auricular cartilage formation. TGF- ß1 exists in the highest concentration and is more important among all of the growth factors released from PRP. So TGF- ß1 can be used as the core ingredient and the indicator for applying PRP in these studies. The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • Taipei Medical University, Wan Fang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • microtia patient

Exclusion Criteria:

  • non microtia patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm A
Chondrocyte culture with FBS medium
Other: Chondrocyte culture with FBS medium
Microtia chondrocyte culture with FBS medium only
Experimental: Arm B
Chondrocyte culture with PRP
Other: Platelet-rich plasma (PRP)
PRP was extracted from total blood and TGF-b1 was used as indicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Study Chair: Chia-Che Wu, MD, Chia-Che Wu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 12, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (Estimate)

August 13, 2009

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-WF-PHD-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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