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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958802
First Posted: August 13, 2009
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Medical University WanFang Hospital
August 12, 2009
August 13, 2009
November 19, 2010
May 2009
August 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00958802 on ClinicalTrials.gov Archive Site
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Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
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.
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Interventional
Early Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Microtia
  • Other: Platelet-rich plasma (PRP)
    PRP was extracted from total blood and TGF-b1 was used as indicator
  • Other: Chondrocyte culture with FBS medium
    Microtia chondrocyte culture with FBS medium only
  • Placebo Comparator: Arm A
    Chondrocyte culture with FBS medium
    Intervention: Other: Chondrocyte culture with FBS medium
  • Experimental: Arm B
    Chondrocyte culture with PRP
    Intervention: Other: Platelet-rich plasma (PRP)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
September 2009
August 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • microtia patient

Exclusion Criteria:

  • non microtia patient
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00958802
98-WF-PHD-05
No
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Chia-Che Wu, MD, Taipei medical university- Wan Fang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Study Chair: Chia-Che Wu, MD Chia-Che Wu
Taipei Medical University WanFang Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP