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

Microtia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958802
• Other study ID #: 98-WF-PHD-05
• Status: Completed
• Phase: Phase 0
• First received: August 12, 2009
• Last updated: November 18, 2010
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2010
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• microtia patient

Exclusion Criteria:

• non microtia patient

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Microtia

Intervention

Other:
• Platelet-rich plasma (PRP)
PRP was extracted from total blood and TGF-b1 was used as indicator
• Chondrocyte culture with FBS medium
Microtia chondrocyte culture with FBS medium only

Locations

Country	Name	City	State
Taiwan	Taipei Medical University, Wan Fang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.		4 weeks	No