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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
  Purpose
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.

Condition Intervention Phase
Microtia Other: Platelet-rich plasma (PRP) Other: Chondrocyte culture with FBS medium Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 6
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • microtia patient

Exclusion Criteria:

  • non microtia patient
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958802


Locations
Taiwan
Taipei Medical University, Wan Fang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Study Chair: Chia-Che Wu, MD Chia-Che Wu
  More Information

Responsible Party: Chia-Che Wu, MD, Taipei medical university- Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT00958802     History of Changes
Other Study ID Numbers: 98-WF-PHD-05
First Submitted: August 12, 2009
First Posted: August 13, 2009
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by Taipei Medical University WanFang Hospital:
tissue engineering

Additional relevant MeSH terms:
Congenital Microtia
Ear Diseases
Otorhinolaryngologic Diseases
Congenital Abnormalities