Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-12 @ 8:15 PM
Study NCT ID:
NCT02910232
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
Sponsor:
Chiang Mai University
Organization:
Study Overview
Official Title:
In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. In this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial.
Detailed Description:
The products were prepared from medical grade Thai rice starch mixed with high purity (\>97%) hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility test, then processed by freeze-drying. There were 44 volunteers from orthopedic and neurosurgical division, 4 and 40 patients, respectively.
Study Oversight
Has Oversight DMC:
True
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?: