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Abstract Details

Imaging Outcomes of a Dopaminergic Neuronal Cell Therapy for Parkinson’s Disease: 18-month Results from a Phase 1 Study of Bemdaneprocel
Movement Disorders
S30 - Movement Disorders: Clinical Trials in Movement Disorders (1:48 PM-2:00 PM)
005
Evaluate [18F]-fluorodopa (18F-DOPA) positron emission tomography (PET) signal 18 months post transplantation (6 months after cessation of immunosuppression) in 12 participants who received intraputamenal transplants of bemdaneprocel.
Bemdaneprocel is an investigational cellular therapy composed of pluripotent stem cell–derived dopaminergic neuron precursor cells under development for the treatment of Parkinson’s disease. At 1 year post transplantation, bemdaneprocel was generally safe and well tolerated in 12 participants. Relative to baseline, increases in putamen 18F-DOPA PET signal indicated successful transplantation and graft survival in the target region.
In this open-label, 24-month, non-controlled study, 12 participants received 1 of 2 doses of bemdaneprocel to the post-commissural putamen bilaterally and a 1-year immunosuppression regimen. Changes from baseline in 18F-DOPA uptake were measured by striatal-to-occipital ratio for each participant within regions of interest defined by voxel-based brain mapping analysis at a group level. Participants were also assessed for morphologic changes by magnetic resonance imaging (MRI) before and after surgery and at multiple time points through year 1.
Compared with baseline, group-level analysis (N=12) of 18F-DOPA uptake at 1 year post transplantation revealed clusters of increased signal within the striatal hypothesis testing space (p<0.05). Whereas increases in 18F-DOPA uptake were discerned along surgical tracts through the putamen (p<0.005), caudate signal declined over the same time interval (p<0.01). MRI demonstrated no changes in target volume over the 1 year post transplantation.
Increased post-transplantation 18F-DOPA PET signal along posterior putamen surgical trajectories is consistent with survival of bemdaneprocel grafts at 1 year. Concurrent MRI assessments of target volume did not reveal evidence of cell overgrowth during the same time period. Additional results will be presented, including imaging data acquired 18 months after transplantation (6 months after the cessation of immunosuppression).
Authors/Disclosures
Claire Henchcliffe, MD, PhD, FAAN (University of California, Irvine)
PRESENTER 		Dr. Henchcliffe has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bayer. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AskBio. Dr. Henchcliffe has received personal compensation in the range of $0-$499 for serving as a Consultant for Certara. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson & Johnson. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Meira GTx. Dr. Henchcliffe has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ProJenX. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Canary Global Inc . Dr. Henchcliffe has stock in Axent Biosciences Inc. The institution of Dr. Henchcliffe has received research support from Weston Brain Institute. The institution of Dr. Henchcliffe has received research support from Blue Rock Therapeutics. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Parkinson Study Group. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Speaker with UCLA. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Speaker travel with World Congress of Neurology. Dr. Henchcliffe has received personal compensation in the range of $0-$499 for serving as a Speaker travel with IAPRD. Dr. Henchcliffe has received personal compensation in the range of $0-$499 for serving as a Speaker travel with ASGCT. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Speaker/Course director with AAN. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Invited speaker with Parkinson Study Group. Dr. Henchcliffe has received personal compensation in the range of $0-$499 for serving as a Speaker with Stanford. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Cleveland Clinic Foundation. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Vertex. Dr. Henchcliffe has received personal compensation in the range of $500-$4,999 for serving as a Speaker with ESGCT.
Yilong Ma, PhD (Feinstein Institute for Medical Research) The institution of Dr. Ma has received research support from AskBio. The institution of Dr. Ma has received research support from Aspen Neuroscience . The institution of Dr. Ma has received research support from Blue Rock . The institution of Dr. Ma has received research support from Bayer.
Harini Sarva, MD, FAAN (Weill Cornell Medical Center) The institution of Dr. Sarva has received research support from Insightec. The institution of Dr. Sarva has received research support from NeuroNext. The institution of Dr. Sarva has received research support from Neuroderm. The institution of Dr. Sarva has received research support from Sun Pharma. The institution of Dr. Sarva has received research support from Prevail. The institution of Dr. Sarva has received research support from Bluerock Therapeutics. The institution of Dr. Sarva has received research support from Biogen. The institution of Dr. Sarva has received research support from Roche. The institution of Dr. Sarva has received research support from National Institute of Aging. The institution of Dr. Sarva has received research support from Michael J Fox Foundation. The institution of Dr. Sarva has received research support from Novo Nordisk. The institution of Dr. Sarva has received research support from Bukwang. The institution of Dr. Sarva has received research support from Bial. The institution of Dr. Sarva has received research support from Cerevance. The institution of Dr. Sarva has received research support from UCB. The institution of Dr. Sarva has received research support from MeiraGTX.
Andres M. Lozano, MD (Toronto Western Hosp) Dr. Lozano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Dr. Lozano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Insightec. Dr. Lozano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Lozano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Lozano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Functional Neuromodulation.
Alfonso Fasano, MD, PhD, FAAN (Toronto Western Hospital - U of Toronto) Dr. Fasano has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbott. Dr. Fasano has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Fasano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Fasano has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Dr. Fasano has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Boston Scientific. Dr. Fasano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbott. Dr. Fasano has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Fasano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ceregate. Dr. Fasano has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Inbrain Neuroelectronics. Dr. Fasano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Syneos Health. Dr. Fasano has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Annovis. Dr. Fasano has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for CADTH. The institution of Dr. Fasano has received research support from Boston Scientific. The institution of Dr. Fasano has received research support from Medtronic. The institution of Dr. Fasano has received research support from Abbvie. The institution of Dr. Fasano has received research support from Canadian Institutes of Health Research (CIHR). The institution of Dr. Fasano has received research support from Michael J Fox Foundation. The institution of Dr. Fasano has received research support from Bluerock Therapeutics. Dr. Fasano has received publishing royalties from a publication relating to health care. Dr. Fasano has a non-compensated relationship as a Medical Advisory Committee with CenteR for Advancing Neurological Innovation to Application (CRANIA) that is relevant to AAN interests or activities. Dr. Fasano has a non-compensated relationship as a Medical Advisory Committee with HopeNET that is relevant to AAN interests or activities. Dr. Fasano has a non-compensated relationship as a Medical Advisory Committee with International Essential Tremor Foundation that is relevant to AAN interests or activities. Dr. Fasano has a non-compensated relationship as a Member with Tremor Research Group that is relevant to AAN interests or activities. Dr. Fasano has a non-compensated relationship as a Co-Chair with Tremor Study Group of the IPMDS that is relevant to AAN interests or activities. Dr. Fasano has a non-compensated relationship as a Vice-Chair with NPH Study Group of the IPMDS that is relevant to AAN interests or activities. Dr. Fasano has a non-compensated relationship as a Vice-Chair with Industry Committee of the IPMDS that is relevant to AAN interests or activities.
Suneil Kalia Suneil Kalia has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbott. Suneil Kalia has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston. Suneil Kalia has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Suneil Kalia has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novonordisk. The institution of Suneil Kalia has received research support from CIHR. Suneil Kalia has received research support from MJFF. The institution of Suneil Kalia has received research support from Parkinson Canada.
Kenny Yu (Memorial Sloan Kettering Cancer Center) Kenny Yu has nothing to disclose.
Cameron Brennan Cameron Brennan has nothing to disclose.
No disclosure on file
Whitney Stemple (BlueRock Therapeutics) Whitney Stemple has received personal compensation for serving as an employee of BlueRock Therapeutics.
Nauman Abid, MD (BlueRock Therapeutics) Dr. Abid has received personal compensation for serving as an employee of BlueRock Therapeutics.
Marcus Yountz, MD, FAAN (BlueRock Therapeutics) Dr. Yountz has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease. Dr. Yountz has stock in AstraZeneca.
Ahmed Enayetallah, PhD, MBBCh (BlueRock Therapeutics) Dr. Enayetallah has received personal compensation for serving as an employee of Alexion. Dr. Enayetallah has received stock or an ownership interest from Alexion. Dr. Enayetallah has received stock or an ownership interest from AstraZeneca.
Antoine Lampron, PhD (Bluerock Therapeutics) Mr. Lampron has received personal compensation for serving as an employee of Bluerock Therapeutics. Mr. Lampron has received personal compensation for serving as an employee of Alexion Inc..
Viviane Tabar Viviane Tabar has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BlueRock. An immediate family member of Viviane Tabar has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BlueRock. The institution of Viviane Tabar has received research support from BlueRock. The institution of an immediate family member of Viviane Tabar has received research support from BlueRock. Viviane Tabar has received intellectual property interests from a discovery or technology relating to health care. An immediate family member of Viviane Tabar has received intellectual property interests from a discovery or technology relating to health care.
David Eidelberg, MD, FAAN (Feinstein Institute for Medical Research) Dr. Eidelberg has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for MeiraGTx. Dr. Eidelberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TreeFrog Therapeutics. Dr. Eidelberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Blue Rock Therapeutics, Inc.. Dr. Eidelberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SANA Biotechnology, Inc. Dr. Eidelberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bio Vie, Inc.. Dr. Eidelberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for KenaiTx, Inc.. Dr. Eidelberg has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aspen Neuroscience. Dr. Eidelberg has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Oxford University Press. The institution of Dr. Eidelberg has received research support from The Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Eidelberg has received research support from Lupus Research Alliance. The institution of Dr. Eidelberg has received research support from National Institutes of Health. The institution of Dr. Eidelberg has received research support from Blue Rock Therapeutics. The institution of Dr. Eidelberg has received research support from National Institute of Neurological Disorders and Stroke. The institution of Dr. Eidelberg has received research support from The Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Eidelberg has received research support from National Institute of Allergy and Infectious Diseases. The institution of Dr. Eidelberg has received research support from Aspen Neurosciences, Inc. . The institution of Dr. Eidelberg has received research support from NIH. Dr. Eidelberg has received intellectual property interests from a discovery or technology relating to health care. Dr. Eidelberg has received intellectual property interests from a discovery or technology relating to health care.