Pluristem stem cell trial to treat muscle injury meets main goal | Reuters


Pluristem’s placental PLX-PAD cells produced show statistically significant improvement over placebo in the change of the maximal contraction force of the gluteal muscle

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, has announced results from its Phase I/II clinical trial that examines the safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury.  This trial showed patients treated with PLX-PAD had a greater improved change of maximal voluntary muscle contraction force than the placebo group.  These results show that PLX cells may have the ability to improve muscle and tendon healing after orthopedic injuries.

This Phase I/II trial was a randomized, placebo-controlled, double-blinded study conducted at the Orthopedic Clinic of the Charité University Medical School under the oversight of the Paul-Ehrlich-Institute (PEI), Germany’s health authority.  The injured muscle studied was the gluteus medius muscle in the buttock. Total hip replacement surgery via the standard transgluteal approach necessitates injury of the gluteus medius muscle, and post-operative healing is crucial for joint stability and function.

The 20 patients in the study were randomized into three treatment groups. Each patient received an injection in the traumatized gluteal muscle that had been injured during hip replacement surgery.  One group was treated with 150 million PLX-PAD cells per dose (n=7), the second was administered 300 million PLX-PAD cells per dose (n=6), and the third received placebo (n=7).

The primary safety endpoint was clearly met, since patients showed no serious adverse events reported at either dose level.  In this study, PLX-PAD cells were safe and well tolerated.

The primary efficacy endpoint of the study was the change in maximal voluntary isometric contraction force of the gluteal muscle at six months after the surgery.  Efficacy was shown in both PLX-PAD treated patient groups, but the patients in the group who had received the 150 million cell dose displayed a statistically significant 500% improvement over the placebo group in the change of the maximal contraction force of the gluteal muscle (p=0.0067).   Patients treated at the 300 million cell dose showed a 300% improvement over the placebo (p=0.18).

The structure of the gluteal muscle was also evaluated by means of magnetic resonance imaging (MRI).  MRI analysis revealed an increase in muscle volume in those patients treated with PLX-PAD cells versus the placebo group.  This efficacy endpoint was demonstrated in both PLX-PAD treated patient groups, with the group receiving the 150 million cell dose displaying a statistically significant superiority over the placebo group.  Patients treated at the 150 million cell dose showed an approximate 300% improvement over the placebo in the analysis of muscle volume (p=0.004).  Patients treated at the 300 million cell dose showed an approximate 150% improvement over the placebo in the change of muscle volume (p=0.19).  The complete dataset that includes biopsy results and functional assessments and will be presented at a medical conferences in the future.

The study’s Senior Scientist, Dr. Tobias Winkler of the Center for Musculoskeletal Surgery, Julius Wolff Institute Berlin, Charité – Universitaetsmedizin Berlin, Germany, commented, “I am very impressed with the magnitude of the efficacy results seen in this trial. PLX cells demonstrated safety and suggested that the increase in muscle volume could be a mechanism for the improvement of contraction force.”

Zami Aberman Chairman and CEO stated, “This was a very important study not only for Pluristem but for the cell therapy industry in general. The study confirms our pre-clinical findings that PLX-PAD cell therapy can be effective in treating muscle injury. Having a statistically significant result for our primary efficacy endpoint is very encouraging and consistent with our understanding of the mechanism of action associated with cell therapy. Based on these results, we intend to move forward with implementing our strategy towards using PLX cells in orthopedic indications and muscle trauma.”

The Stem Cell Blog

  • cells were safe and well tolerated
  • one group receiving a 150 million cell dose displaying a 500 percent improvement over the placebo group.
  • Patients treated with a 300 million cell dose showed a 300 percent improvement over the placebo.
  • An analysis of the gluteal muscle indicated an increase in muscle volume in those patients treated…versus the placebo group.

Pluristem stem cell trial to treat muscle injury meets main goal

TEL AVIV Tue Jan 21, 2014 3:07am EST

(Reuters) – Pluristem Therapeutics Inc said results from its early/mid-stage clinical trial indicated its placenta-derived stem cells for the treatment of muscle injury were safe and provided evidence the cells might be effective in treating orthopedic injuries.

\”Patients treated with PLX-PAD had a greater improved change of maximal voluntary muscle contraction force than the placebo group,\” Israel-based Pluristem said in a statement on Tuesday.

The trial was conducted at the Orthopedic Clinic of…

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British Hospital Refuses to Hydrate a Dehydrated Patient: Hospital Administrators Hide and the Patient Died


I lived in Great Britain for three years (1994-1997) and have first-hand experience with the National Health Service. Needless to say, I was not impressed. They do fine with child-birth and then abandon older people to their own fate. Nationalized health care is rationed health and do not let anyone tell you differently. When you become old enough, the health service you spent your whole life paying into abandons you in your time of greatest need. Now we have a stark example of this.

Wesley Smith has a blog entry on this. It will make you sick. According to the British newspaper, The Daily Mail, a desperate hospital patient died after he was denied hydration by the hospital. To get hydration, he called the police and begged them to bring him a drink. The patient, Kane Gorny, 22, needed drugs to regulate his hormone levels after successfully beating brain cancer months earlier. However, during a further hospital stay nurses forgot to give him his medication and he became so delirious he was forced to call 999 (the UK equivalent of 911) to ask for help. The police officers went to St George’s Hospital in Tooting, south London, but were turned away by staff who insisted that Mr Gorny was fine. Gorny had been admitted in May 2009 to undergo hip replacement surgery after his bones became brittle. This was a side-effect of his prescribed steroids. Kane’s mother, Rita Cronin, said she spent hours trying to convince hospital staff that Kane needed urgent attention but was repeatedly “told he was alright.” See http://www.dailymail.co.uk/news/article-2167643/Patient-dying-thirst-rang-999-Inquest-hears-mothers-fury-nurses-neglected-son.html for the article.

An inquiry into the matter has been initiated by the Crown Prosecution Service at the behest of Gorny’s parents.  Kane Gorny had surgery on his pituitary gland, and he had problems regulating his levels of salt and water in his system.  Pituitary surgery commonly damages that back part of the pituitary gland and this prevents the release of antidiuretic hormone (ADH, also known as vasopressin).  Without ADH, patients have a condition called diabetes insipidus, and they need to take exogenous ADH.  Without exogenous ADH, the patient will urinated themselves to death.  The nurses failed to give him his medicine, and dismissed his concerns and the concerns of his mother.  Because he was so dehydrated, Kane called the police to get some fluid, but the nurses at the hospital dismissed them.  He died from dehydration and abnormally sodium levels.  His death was almost certainly a painful one.

The inquiry will probably result in some nurses being sacked (British for fired), but the status quo will probably be maintained.  This kind of abuse is more routine in the British Health System than they would probably admit.  Doctors have even started to prescribe water to elderly patients to prevent them from dying from dehydration.  Is this what we want for the US?