Pluristem Therapeutics, Inc., a developer of placenta-based cell therapies, announced August 14 the results of a pre-clinical trial using the company’s PLacental eXpanded (PLX) cells in tendon injury. Scott Rodeo, M.D. and his orthopedic research team at New York’s Hospital for Special Surgery (HSS) studied the effects of PLX cells on rat patellar tendons that had sustained collagenase-induced injuries.
Pluristem: PLX Cells and Tendon Healing
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“Cell-based approaches clearly have great potential for the augmentation of connective tissue healing, as well as for tissue regeneration. As an ‘off the shelf’ cell source, PLX cells could provide an effective option to improve tendon healing, ” stated Dr. Rodeo, in the news release. Dr. Rodeo is principal investigator for this study and professor of Orthopedic Surgery at Weill Cornell Medical College. Dr. Rodeo is co-chief of the Sports Medicine and Shoulder Service at Hospital for Special Surgery; associate team physician for the New York Giants Football Team; and physician for the U.S.A. Olympic Swimming Team.
“Pluristem is extremely pleased that the results of this pre-clinical trial validate our strategy to pursue the use of our PLX cells for tendon injuries and other orthopedic indications. We look forward to the results of our recently fully-dosed, Phase I/II clinical trial in Germany using our PLX cells in muscle injury, ” stated Zami Aberman, chairman and CEO of Pluristem.
PLX-treated tendons demonstrated better early structural properties at 2 and 4 weeks compared to saline-treated controls. This was evident based on statistically significant higher load-to-failure properties at 2 weeks following injection. Additionally, the demonstrated higher mean load-to-failure and stiffness properties were maintained at 4 weeks. These improved biomechanical properties may be related to the findings of a greater proteoglycan and collagen content seen at the tendon-bone interface of PLX-treated samples.
Aberman told OTW, “Pluristem is developing a pipeline of therapeutics for a variety of indications based on our patented PLX (PLacental eXpanded) cells. It is estimate that during 2014 we will have strong evidence that PLX cells have unique therapeutic effects for a variety of indications such as: muscle injuries, bone marrow failures and preeclampsia as well as having ongoing clinical studies in intermittent claudication (IC), critical limb ischemia (CLI), pulmonary hypertension (PAH) and tendon injuries.”
He added, “We have completed the enrollment of all patients in the Phase I/II muscle injury study within about 6-months from the start of the study and it is estimated that the data from the 6-month follow-up could potentially be released during the first quarter of 2014. We strongly believe that the use of PLX cells following orthopedic injuries such as muscle and tendon injuries could potentially improve the quality of life of the patients in the U.S. and around the world.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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