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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00958802
Other study ID # 98-WF-PHD-05
Secondary ID
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


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
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