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

NCT ID: NCT00958802

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Microtia

Keywords

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tissue engineering

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Chondrocyte culture with FBS medium

Group Type PLACEBO_COMPARATOR

Chondrocyte culture with FBS medium

Intervention Type OTHER

Microtia chondrocyte culture with FBS medium only

Arm B

Chondrocyte culture with PRP

Group Type EXPERIMENTAL

Platelet-rich plasma (PRP)

Intervention Type OTHER

PRP was extracted from total blood and TGF-b1 was used as indicator

Interventions

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Platelet-rich plasma (PRP)

PRP was extracted from total blood and TGF-b1 was used as indicator

Intervention Type OTHER

Chondrocyte culture with FBS medium

Microtia chondrocyte culture with FBS medium only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* microtia patient

Exclusion Criteria

* non microtia patient
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taipei medical university- Wan Fang Hospital

Principal Investigators

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Chia-Che Wu, MD

Role: STUDY_CHAIR

Chia-Che Wu

Locations

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Taipei Medical University, Wan Fang Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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98-WF-PHD-05

Identifier Type: -

Identifier Source: org_study_id