Viewing Study NCT01078493


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Study NCT ID: NCT01078493
Status: WITHDRAWN
Last Update Posted: 2016-09-26
First Post: 2010-02-27
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Wrinkle Injection With Autologous Platelet Rich Plasma Study
Sponsor: Novena Medical Center
Organization:

Study Overview

Official Title: Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles
Status: WITHDRAWN
Status Verified Date: 2016-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Protocol revision necessary.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: WIPES
Brief Summary: Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery such as the surgical repair of facial defects. Results from these clinical trials suggest that PRP helps in collagen formation and organisation to promote healing of tissues. This study attempts to document the clinical effects of intradermal injection of PRP on wrinkles.
Detailed Description: 10 selected participants will have 10 ml of blood removed for platelet extraction with MyCells®. The resulting Platelet rich plasma will be injected intradermally into the facial wrinkles.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: