A phase 1 clinical trial recently released in the Brigham general mass is examining the safety and viability of an innovative treatment approach to Parkinson’s disease in which a patient’s stem cells are reprogrammed to replace dopamine cells in the brain damaged by the disease. The first essay of an autologous stem cell transplant, based on invented and validated research and technologies in the McLean Hospital Neuroregeneration Research Institute (NRI), has registered and treated three patients at the Brigham and Women’s Hospital Hospital.
A total of six participants in phase 1 test will be included that will track patients for 12 months and more to determine the safety of the procedure and monitor any improvements in Parkinson’s disease. After the first 6 transplanted patients in the phase 1 study, researchers hope to expand and recruit more patients as part of the phase 2A study.
This new therapeutic approach to treat Parkinson’s disease incorporates the use of stem cells derived from the blood of a patient who had become induced pluripotent stem cells (IPSC). These cells are reprogrammed to become dopaminergic neurons of the specific medium brain ready for transplantation. The autologous transplant approach to the use of a person’s cells avoids the requirement of immunosuppressive treatments, which are necessary when cells of other donors are used.
Cell replacement for Parkinson’s disease replaces dopamine neurons lost by degeneration and can restore the dopaminergic function in the brain, providing a completely new treatment modality compared to currently available treatments. The founding director of the NRI, Ole Isacson, Dr. Med Sci, who is also a professor of neurology (neuroscience) at the Harvard Medicine Faculty and Mass Brigham’s general, has been a pioneer in cell therapy for Parkinson’s disease in the last 30 years and has established the bases for this clinical trial.
“Seeing this new transformative replacement based on patient cells of their own dopamine neurons to reach very basic science advances in our laboratory to completely translate to a clinical application for the patient’s suffering of Parkinson’s disease, is very gratifying,” Isacson said. “We believe that this approach can open a new treatment paradigm and lead to the development of many additional cell therapies to restore damaged brain systems and replace degenerate brain cells in other diseases.”
Under Isacson’s Leadership, The Nri at McLean has revealed and patented Autologous Cell-Based Restoration in Parkinson’s Disease with a Pioneering preclinical publication in 2002 using Stem Cells and the first preclinical demonstration of Effective Human IPS Cell-Derned Dopamine Neuron Neuron Use In 2010. In 2015, The Nri Team, LED by Isacson and Penny Hallett, PHD, Co-Director of the Nri AT McLean and Associate The professor of psychiatry at Harvard’s Faculty of Medicine, provided the first long-term security evidence and benefits of autologous stem cell therapy in a model of non-human animals highly relevant to Parkinson’s disease.
The NRI received the official authorization of the United States Food and Medicines Administration (FDA) on August 23, 2023, approving its application of new research medications (IND) for a phase 1 clinical trial to prove this unique autologous autologous dopamine neurons therapy.
Following this Fda Approval for the Phase 1 Clinical Trial, The Nri’s Innovative preclinical work was translated into the clinic with the first patient treated on sepchermber 9, 2024. This Collaboration includes nri investigators James Schumacher, MD, and Oliver Cooper, PHD, and Colle. Neurology (Michael Hayes, MD) and Neurosurgery (John Rolston, MD, PHD, main investigation of the phase 1) departments at the Brigham and Women’s hospital. Isacson does not participate directly in the clinical trial because he is the head of innovative technology patents and also co -founder of Oryon Cell Therapies, which has the license for this technology. The trial is led by Hallett and his colleagues within the health system of Mass Brigham General and his institutions affiliated with Harvard Medical School.
“It is extraordinary to witness that our institution’s researchers can bring new treatments to patients throughout the” Banking to bed “laboratory process, and inspires many researchers to similarly pursue their scientific and medical ideas to reach needy patients,” said Kerry Ressler MD, PHD, chief scientific director of the McLean hospital.
The phase 1 clinical trial will be the first essay of this type that evaluates autologous Dopamine neurons derived from IPSS derived from blood in patients with Parkinson’s disease and is funded by the National Institute of Neurological Disorders and Stros of the National Institute of Health (NINDS) of the National Health Institute. NINDS granted highly competitive cooperative research to enable and advance in translation companies for biological (create Bio) for this work in 2020.
People looking for more information in the test can send an email: @bwh.harvard.edu “Title =” MAILTO: NEUROSURGERYCR@BWH.harvard.edu “> neurosurgerycrc@bwh.harvard.edu
For more information:
- The MClean hospital receives the coveted NIH subsidy to clinically study the autologous stem cell therapy for Parkinson’s disease
- Patient -derived stem cells could improve drug research for Parkinson’s
Funds: The study was supported by a Bio Nifs Bio subsidy (U01NS109463).
The content is the exclusive responsibility of the authors and does not necessarily represent the official NIH opinions.
Divulgation:Isacson has co -founded a company (Oryon Cell Therapies) that has licensed patents and knowledge to develop autologous cellular therapies for Parkinson’s disease. Isacson’s interests were reviewed and are administered by McLean Hospital and Mass Brigham general according to their conflict policies.
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