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

This study has been completed.
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT00958802
First received: August 12, 2009
Last updated: November 18, 2010
Last verified: November 2010
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • microtia patient

Exclusion Criteria:

  • non microtia patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 12, 2009
Last Updated: November 18, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
tissue engineering

ClinicalTrials.gov processed this record on May 23, 2013