The International Perinatal Stem Cell Society, Inc. and TRI-PAC Health and Wellness Advocacy have formed a strategic alliance to advocate for legal access to safe, effective, and affordable stem cell therapies in the United States. They propose adopting the Japanese model for stem cell therapy regulation, allowing patients to participate in paid clinical trials. The partnership aims to draft and propose a federal bill to improve patient access to stem cell and tissue therapies.
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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. 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. |
Kyle CetruloStem Cells from My Perspective Archives
August 2024
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