- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Trial completion: Assessment of the Quality and Quantity of Bone Regeneration (clinicaltrials.gov) - Oct 12, 2020
P=N/A, N=11, Completed,
Comparative, multicenter trials and outcome registries free from industry COIs are indicated. Active, not recruiting --> Completed
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Preclinical, Journal: Comparing cellular bone matrices for posterolateral spinal fusion in a rat model. (Pubmed Central) - Jul 3, 2020
We aim to compare the ability of six commercially-available human CBMs (Trinity ELITE®, ViviGen®, Cellentra®, Osteocel® Pro, Bio4® and Map3®) to form a stable spinal fusion using an athymic rat model of posterolateral fusion...Trinity ELITE and Cellentra were significantly better than other implants at forming new bone and achieving spinal fusion in this rat model at week 6. These results suggest that there may be large differences in the ability of different CBMs to elicit a successful fusion in the posterolateral spine.
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Preclinical, Journal: A Comparative Evaluation of Commercially Available Cell-Based Allografts in a Rat Spinal Fusion Model. (Pubmed Central) - May 2, 2020
The Trinity Evolution and Trinity ELITE cellular bone allografts were more effective at creating posterolateral fusion than either the Osteocel Plus allografts or syngeneic bone in this animal model. The superior fusion rate of Trinity cellular bone allografts may lead to better clinical outcome of spinal fusion surgeries.
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Preclinical, Journal: Comparative Efficacy of Commonly Available Human Bone Graft Substitutes as Tested for Posterolateral Fusion in an Athymic Rat Model. (Pubmed Central) - Nov 22, 2019
Grafting material products implanted were demineralized bone matrix (DBM)-based allografts (Accell EVO3, DBX Mix, DBX Strip, Grafton Crunch, Grafton Flex, Grafton Matrix, Grafton Putty, Magnifuse, and Progenix Plus), allografts (OsteoSponge, MinerOss), cellular allograft (Osteocel Plus), ceramics (Mozaik Strip), or activated ceramics (Actifuse ABX Putty, Vitoss BA)...Whole allograft and ceramics may provide osteoconductive scaffolding for mixed-material grafting; however, surgeons should be cautious in using them alone. Direct clinical data are needed to establish efficacy for any bone graft substitute.
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Trial completion date: Assessment of the Quality and Quantity of Bone Regeneration (clinicaltrials.gov) - Jul 11, 2019
P=N/A, N=11, Active, not recruiting,
Direct clinical data are needed to establish efficacy for any bone graft substitute. Trial completion date: May 2019 --> Jul 2020
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Review, Journal: Allogenic Stem Cells in Spinal Fusion: A Systematic Review. (Pubmed Central) - Jun 4, 2019
Fusion rates varied across time frames and intervention products in case series. The overall quality (strength) of evidence of effectiveness and safety of allogenic stem cells products for lumbar and cervical arthrodesis was very low, meaning that we have very little confidence that the effects seen are reflective of the true effects.
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Enrollment closed: Assessment of the Quality and Quantity of Bone Regeneration (clinicaltrials.gov) - Jan 8, 2019
P=N/A, N=11, Active, not recruiting,
The overall quality (strength) of evidence of effectiveness and safety of allogenic stem cells products for lumbar and cervical arthrodesis was very low, meaning that we have very little confidence that the effects seen are reflective of the true effects. Recruiting --> Active, not recruiting
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Enrollment change: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=51, Completed,
Initiation date: Jan 2018 --> Nov 2017 N=70 --> 51
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Enrollment change: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=104, Completed,
N=70 --> 51 N=150 --> 104
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Enrollment change: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=19, Completed,
N=150 --> 104 N=50 --> 19
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Enrollment change: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=28, Completed,
N=50 --> 19 N=70 --> 28
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Trial completion: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=51, Completed,
N=70 --> 28 Active, not recruiting --> Completed
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Trial completion: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=104, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Trial completion: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=19, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Trial completion: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=182, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Osteocel-XC (mesenchymal stem cells) / Osiris
Trial completion: Osteocel (clinicaltrials.gov) - May 16, 2013
P=N/A, N=28, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
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