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

NCT00958802 | Completed Early Phase 1

• 1 other identifier: 98-WF-PHD-05
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microtia

Keywords

tissue engineering

Outcome Measures

Primary Outcomes (1)

• The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.

  4 weeks

Study Arms (2)

Arm A

PLACEBO COMPARATOR

Chondrocyte culture with FBS medium

Other: Chondrocyte culture with FBS medium

Arm B

EXPERIMENTAL

Chondrocyte culture with PRP

Other: Platelet-rich plasma (PRP)

Interventions

Platelet-rich plasma (PRP) OTHER

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

Arm B

Chondrocyte culture with FBS medium OTHER

Microtia chondrocyte culture with FBS medium only

Arm A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• microtia patient

You may not qualify if:

• non microtia patient

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University, Wan Fang Hospital

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chia-Che Wu, MD

  Chia-Che Wu

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 19, 2010

Record last verified: 2010-11

Locations

TW (1)