PMID- 33049918
OWN - NLM
STAT- MEDLINE
DCOM- 20210702
LR  - 20211204
IS  - 2073-4409 (Electronic)
IS  - 2073-4409 (Linking)
VI  - 9
IP  - 10
DP  - 2020 Oct 8
TI  - Safety and Tolerability of Stromal Vascular Fraction Combined with beta-Tricalcium 
      Phosphate in Posterior Lumbar Interbody Fusion: Phase I Clinical Trial.
LID - 10.3390/cells9102250 [doi]
LID - 2250
AB  - The rates of pseudarthrosis remain high despite recent advances in bone graft 
      substitutes for spinal fusion surgery. The aim of this single center, 
      non-randomized, open-label clinical trial was to determine the feasibility of 
      combined use of stromal vascular fraction (SVF) and beta-tricalcium phosphate 
      (beta-TCP) for patients who require posterior lumbar interbody fusion (PLIF) and 
      pedicle screw fixation. Two polyetheretherketone (PEEK) cages were inserted into 
      the intervertebral space following complete removal of the intervertebral disc. 
      The PEEK cage (SVF group) on the right side of the patient was filled with beta-TCP 
      in combination with SVF, and the cage on the left side (control group) was filled 
      with beta-TCP alone. Fusion rate and cage subsidence were assessed by lumbar spine 
      X-ray and CT at 6 and 12 months postoperatively. At the 6-month follow-up, 54.5% 
      of the SVF group (right-sided cages) and 18.2% of the control group (left-sided 
      cages) had radiologic evidence of bone fusion (p = 0.151). The 12-month fusion 
      rate of the right-sided cages was 100%, while that of the left-sided cages was 
      91.6% (p = 0.755). Cage subsidence was not observed. Perioperative combined use 
      of SVF with beta-TCP is feasible and safe in patients who require spinal fusion 
      surgery, and it has the potential to increase the early bone fusion rate 
      following spinal fusion surgery.
FAU - Choi, Un Yong
AU  - Choi UY
AUID- ORCID: 0000-0001-9331-1112
AD  - Department of Neurosurgery, CHA Bundang Medical Center, CHA University, 
      Seongnam-si 13496, Korea.
FAU - Kim, Kyoung-Tae
AU  - Kim KT
AUID- ORCID: 0000-0003-4867-6854
AD  - Department of Neurosurgery, School of Medicine, Kyungpook National University, 
      Daegu 41944, Korea.
AD  - Department of Neurosurgery, Kyungpook National University Hospital, Daegu 41566, 
      Korea.
FAU - Kim, Kwang Gi
AU  - Kim KG
AUID- ORCID: 0000-0001-9714-6038
AD  - Department of Biomedical Engineering, College of Medicine, Gachon University, 
      Seongnam-si 13120, Korea.
AD  - Department of Health Sciences and Technology, Gachon Advanced Institute for 
      Health Sciences and Technology (GAIHST), Gachon University, Seongnam-si 13120, 
      Korea.
FAU - Lim, Sang Heon
AU  - Lim SH
AUID- ORCID: 0000-0002-1298-5180
AD  - Department of Biomedical Engineering, College of Medicine, Gachon University, 
      Seongnam-si 13120, Korea.
AD  - Department of Health Sciences and Technology, Gachon Advanced Institute for 
      Health Sciences and Technology (GAIHST), Gachon University, Seongnam-si 13120, 
      Korea.
FAU - Kim, Young Jae
AU  - Kim YJ
AUID- ORCID: 0000-0003-0443-0051
AD  - Department of Biomedical Engineering, College of Medicine, Gachon University, 
      Seongnam-si 13120, Korea.
FAU - Sohn, Seil
AU  - Sohn S
AD  - Department of Neurosurgery, CHA Bundang Medical Center, CHA University, 
      Seongnam-si 13496, Korea.
FAU - Sheen, Seung Hun
AU  - Sheen SH
AUID- ORCID: 0000-0002-0454-8810
AD  - Department of Neurosurgery, CHA Bundang Medical Center, CHA University, 
      Seongnam-si 13496, Korea.
FAU - Heo, Chan Yeong
AU  - Heo CY
AUID- ORCID: 0000-0001-9003-7365
AD  - Department of Plastic and Reconstructive Surgery, Seoul National University 
      Bundang Hospital, Seongnam-si 13620, Korea.
FAU - Han, Inbo
AU  - Han I
AUID- ORCID: 0000-0002-0834-9325
AD  - Department of Neurosurgery, CHA Bundang Medical Center, CHA University, 
      Seongnam-si 13496, Korea.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20201008
PL  - Switzerland
TA  - Cells
JT  - Cells
JID - 101600052
RN  - 0 (Benzophenones)
RN  - 0 (Calcium Phosphates)
RN  - 0 (Ketones)
RN  - 0 (Polymers)
RN  - 0 (beta-tricalcium phosphate)
RN  - 31694-16-3 (polyetheretherketone)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
SB  - IM
MH  - Adipose Tissue/metabolism
MH  - Aged
MH  - Benzophenones
MH  - Calcium Phosphates/metabolism/*pharmacology
MH  - Female
MH  - Humans
MH  - Ketones/pharmacology
MH  - Male
MH  - Mesenchymal Stem Cell Transplantation/methods
MH  - Mesenchymal Stem Cells/*metabolism
MH  - Middle Aged
MH  - Polyethylene Glycols/pharmacology
MH  - Polymers
MH  - Pseudarthrosis/surgery/*therapy
MH  - Spinal Fusion/methods
MH  - Treatment Outcome
PMC - PMC7600447
OTO - NOTNLM
OT  - bone graft substitute
OT  - posterior lumbar interbody fusion
OT  - spinal stenosis
OT  - stromal vascular fraction
COIS- The authors declare no conflict of interest.
EDAT- 2020/10/15 06:00
MHDA- 2021/07/03 06:00
PMCR- 2020/10/01
CRDT- 2020/10/14 01:02
PHST- 2020/09/09 00:00 [received]
PHST- 2020/10/03 00:00 [revised]
PHST- 2020/10/06 00:00 [accepted]
PHST- 2020/10/14 01:02 [entrez]
PHST- 2020/10/15 06:00 [pubmed]
PHST- 2021/07/03 06:00 [medline]
PHST- 2020/10/01 00:00 [pmc-release]
AID - cells9102250 [pii]
AID - cells-09-02250 [pii]
AID - 10.3390/cells9102250 [doi]
PST - epublish
SO  - Cells. 2020 Oct 8;9(10):2250. doi: 10.3390/cells9102250.