As a huge fan of Ozzy Osbourne and Black Sabbath, I am thrilled by today’s news that Ozzy is receiving stem cell therapy for his Parkinson's disease. The FoxNews article shines a light on the major issues with access to a stem cell therapy in the United States.
The reasons stated for undergoing the stem cell therapy is his desire to be healthy, spend time with family, and see his grandchildren grow up. These are fundamental rights we all share - rights that stem cell treatments can help make possible. Ozzy's daughter Kelly has already described the "mind blowing progress" he's made just three months after treatment. This isn't surprising - stem cells are incredible healing tools. When manufactured following proper protocols, stem cell therapy is actually very safe, as over 5,000 phase one clinical trials have demonstrated. In the article they quote Dr. Mikkael Sekeres, chief of the division of hematology of Sylvester Cancer Center at the University of Miami. The authors don't grasp the difference between a mesenchymal stem cell treatment which Ozzy most likely received and a hemopoietic stem cell transplant. Dr. Mikkael Sekeres states “"Use of stem cells in this way has saved tens of thousands of lives," he noted. "Stem cell therapy given for other reasons is largely experimental and unproven," Sekeres noted. What Dr. Sekeres fails to mention is that the use of hematopoietic stem cell was experimental and unproven before they created a regulatory system that allows the National Marrow Donor Program to perform every single hematopoietic stem cell transplantation under a single open IND/clinical trial. This IND Allows for any transplant physician and any transplant center to join this clinical trial it also allows to treat 99,999 patients. While the FDA has an open IND/clinical trial system allowing widespread access to hematopoietic stem cells to treat blood cancers, no such pathway exists for mesenchymal stem cells - despite them not requiring the same rigorous donor matching. My question is why not? It's unacceptable that in the country with the world's greatest hospitals, patients commonly travel to Mexico, Costa Rica or Colombia for stem cell treatments. We need to reform our laws to expand access here at home. Experts caution patients to be wary of stem cell treatments lacking proper approvals and oversight. Valid concern, but also a consequence of a broken system forcing patients to take risks either abroad. I wish the experts who express so much caution also offered up real solutions. Organizations like the Perinatal Stem Cell Society are working to drive these necessary regulatory changes but we need your help. It's time to create a clear, streamlined pathway for clinically validated stem cell therapies to reach all who could benefit - not just the privileged few. With the right regulatory framework, potentially groundbreaking treatments could be accessible, affordable and properly overseen right here in the United States. Patients battling devastating diseases deserve no less. The current system fails us all. Listen to War Pigs and think about why we don't have stem cell access in the US.
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Highly Successful Covid Trial Opens the Door to Saving Lives in Multiple Severe Lung Diseases5/1/2024 Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) Show Promising Results in Treating Severe COVID-19 Cases I believe that this study will be included in the history of perinatal stem cell's most influential papers as it opens the door for other severe lung diseases to be treated with UC-MSCs.. Although 91% of Covid patients were cured with the expanded umbilical cord stem cell treatment, this treatment options but is currently stalled before the Phase III clinical trial. The COVID-19 pandemic has led researchers to explore various treatment options, and one promising avenue is the use of umbilical cord mesenchymal stem cells (MSCs). A recent study conducted by researchers at the Diabetes Research Institute and collaborating institutes worldwide has shown that MSCs can significantly reduce serious adverse events and mitigate the cytokine storm in severe cases of COVID-19. #COVID19 #MSCs #CellTherapy In a double-blind, randomized controlled trial, 24 subjects with COVID-19-associated acute respiratory distress syndrome (ARDS) were divided into two groups. One group received MSC treatment, while the other received a vehicle solution without cells. The results were remarkable, with the MSC group experiencing a significant decrease in serious adverse events compared to the control group. #ClinicalTrial #ARDS One of the most striking findings was the profound effect of MSCs on the cytokine storm, a life-threatening condition characterized by an overactive immune response. The infusion of MSCs led to a marked reduction in pro-inflammatory cytokines, including TNF-alpha, which plays a crucial role in the cytokine storm. #CytokineStorm #Immunomodulation Moreover, patients in the MSC group demonstrated faster recovery times, with the majority recovering within two weeks. In contrast, most of the surviving patients in the control group were still hospitalized at the one-month mark. This significant improvement in recovery time highlights the potential of MSCs in treating severe COVID-19 cases. #RecoveryTime #PatientOutcomes The success of this trial not only demonstrates the safety and efficacy of MSCs in treating COVID-19 but also paves the way for their application in other immune-mediated diseases. The powerful anti-inflammatory and immunomodulatory effects of MSCs could be harnessed to treat a wide range of conditions. #InflammatoryDiseases #FutureMedicine The promising results of this study on umbilical cord mesenchymal stem cells offer hope for patients with severe COVID-19 and provide a foundation for further research into the potential of cell therapy in treating various diseases. If only the regulatory framework was different to allow patients to access this stem cell treatment. The Paper can be found Here. Here is the Full Lecture from Dr. Ricordi recorded at the 10th Perinatal Stem Cell Society Congress. (,“I’m Fed Up Arnold and I Don’t Care Who Knows It.” - Arnold Horshack
There was a scene from the 1975-1979 Classic TV Sitcom ”Welcome Back Kotter” where Arnold Horshack is on the class Radio show and he gives a moving monologue about being fed up with Reality. He tells his listeners that if they feel the same way as he does to go to the window and yell out to the city, “I’m fed up Arnold and I don’t care who knows It.” Arnold goes to the window and yells out “I’m fed up Arnold and I don’t care who knows It.” Long dramatic silent pause. And then a distant “I’m fed up Arnold and I don’t care who knows It.” And another, “I’m fed up Arnold and I don’t care who knows It.” And Arnold feels better because he isn’t alone. Here is an article that Dr. Rouzbeh Taghizadeh wrote most of and I contributed enough of the content to be listed as an author. This was our company Auxocell Laboratories, Inc. position paper in 2010 that was published in the International Society for Cell and Gene Therapy (ISCT) Newsletter. In 2010, Osiris Therapeutics was about to be approved as the world’s first stem cell therapy in Canada (2012) and then New Zealand (2012) and it was to usher in the golden and marvelous age of stem cell therapy. This drug is a last line of defense for children who undergo cancer treatments and then their body rejects the stem cell treatment to restore their immune system. The approved approach of steroid treatment fails leaving the child with a 90% mortality rate. This drug now is called Remestemcel-L and Remestmyal is still not approved in the US when write this In April 2024. (See Remestemcel-L Powerpoint Presentation) The tiny incremental advances to the clinic and patients make me want to go to my window and yell “I’m fed up Arnold and I don’t care who knows It,” right now. Today, I am even more solidly convinced 14 years later that Perinatal derived stem cell, tissue and exosome therapies will be the most efficacious, safest, easiest to administer as well as the most cost-effective source of stem cells Please help me to correct the regulatory framework our society has accepted as the only way to regulate these incredible stem cells and tissue products and allow access to stem cell therapy in the US. Help me to change the law! |
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