PMID- 15725680
OWN - NLM
STAT- MEDLINE
DCOM- 20050426
LR  - 20190608
IS  - 1341-1357 (Print)
IS  - 0007-5124 (Linking)
VI  - 54
IP  - 1
DP  - 2005 Jan
TI  - Biocompatibility and long-term toxicity of InnoPol implant, a biodegradable 
      polymer scaffold.
PG  - 37-52
AB  - InnoPol, a poly((D,L)-lactic-co-glycolic acid) [PLGA] 65/35 scaffold manufactured 
      by special gas foaming methods in Korea, was subjected to tests to evaluate the 
      degradation and tissue compatibility characteristics and long-term systemic 
      toxicity in mice and rats. C57BL/6 mice and SD rats were implanted subcutaneously 
      with 3-mm- and 1-mm-thick InnoPol circular discs, 10 mm in diameter, 
      respectively, and sacrificed 8, 12, and 24 weeks after implantation. No test 
      material-related effects were observed in mortality, clinical signs, body weight 
      gain, food and water consumption, ophthalmologic signs, urinalysis, hematology, 
      serum biochemistry parameters and organ weights of all animals implanted with 
      InnoPol. Also, there were no systemic symptoms including metabolic alterations 
      and inflammatory reactions in either mice or rats. In addition, no gross 
      pathological findings, except skin lesions around the implantation sites, were 
      found in the major organs. Although mild inflammation at the site of InnoPol 
      implantation was confirmed from hematoxylin and eosin or Masson's trichrome 
      staining at 8-12 weeks, the reactions had disappeared at 24 weeks following 
      complete degradation of the scaffold, leaving granulomatous tissues that were 
      similar to surgical wounds in sham operation controls without implants. These 
      results suggest that InnoPol possesses good mechanical properties and tissue 
      compatibility and does not cause any systemic toxicity other than transient local 
      inflammatory reactions at the implantation site, and that it might be useful in 
      applications as a medical device for implantation.
FAU - Kang, Byeong-Cheol
AU  - Kang BC
AD  - Department of Experimental Animal Research, Seoul National University Hospital, 
      Korea.
FAU - Kang, Kyung-Sun
AU  - Kang KS
FAU - Lee, Yong-Soon
AU  - Lee YS
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Japan
TA  - Exp Anim
JT  - Experimental animals
JID - 9604830
RN  - 0 (Biocompatible Materials)
RN  - 0 (Glycolates)
RN  - 1SIA8062RS (Polylactic Acid-Polyglycolic Acid Copolymer)
RN  - 26009-03-0 (Polyglycolic Acid)
RN  - 33X04XA5AT (Lactic Acid)
SB  - IM
MH  - *Absorbable Implants
MH  - Animals
MH  - *Biocompatible Materials
MH  - Body Weight
MH  - Drinking
MH  - Eating
MH  - *Glycolates/toxicity
MH  - Hematologic Tests
MH  - Lactic Acid
MH  - Male
MH  - Materials Testing
MH  - Mice
MH  - Mice, Inbred C57BL
MH  - Organ Size
MH  - Polyglycolic Acid
MH  - Polylactic Acid-Polyglycolic Acid Copolymer
MH  - Rats
MH  - Rats, Sprague-Dawley
MH  - Subcutaneous Tissue/pathology
MH  - Time Factors
EDAT- 2005/02/24 09:00
MHDA- 2005/04/27 09:00
CRDT- 2005/02/24 09:00
PHST- 2005/02/24 09:00 [pubmed]
PHST- 2005/04/27 09:00 [medline]
PHST- 2005/02/24 09:00 [entrez]
AID - JST.JSTAGE/expanim/54.37 [pii]
AID - 10.1538/expanim.54.37 [doi]
PST - ppublish
SO  - Exp Anim. 2005 Jan;54(1):37-52. doi: 10.1538/expanim.54.37.