Abstract
Objective
- To continue evaluating the effects of bemdaneprocel on motor, non-motor, and quality of life outcomes up to 24 months post transplantation, 12 months post discontinuation of immunosuppression, in participants with PD.
Methods
- Participants with PD, with motor symptoms inadequately controlled by standard treatments, and who were >=50 to <=78 years of age in Canada or >=60 to <=78 years of age in the United States were eligible to enroll in the study.
- A total of 12 participants enrolled sequentially.
- Bemdaneprocel was administered stereotactically into the posterior putamen bilaterally through a single burr hole on each side in a single session.
- Immunosuppression was initiated during transplantation and continued for 1 year post transplantation.
- Secondary motor outcomes included adjusted PD diary good ON time and MDS-UPDRS Part III OFF.
- Exploratory motor and non-motor outcomes included MDS-UPDRS Part II, MDS-UPDRS Part III ON, adjusted PD diary OFF time, 39-item Parkinson’s Disease Questionnaire (PDQ-39), PD Non-motor Symptom Scale (PD NMSS), and the Neuropsychiatric Inventory Questionnaire (NPI-Q).
Conclusions
- Participants who received bemdaneprocel, particularly those in the high-dose cohort, experienced improvement or stability across most secondary and exploratory motor, non-motor, and quality of life outcomes through 24 months post transplantation, 12 months post discontinuation of immunosuppression.
- Improvements in self-reported good ON times and OFF times, as well as motor function while off medication, were observed sooner after transplantation and were more pronounced in the high-dose cohort.
- All participants have enrolled in a continued-evaluation study (NCT05897957) for ongoing evaluation of safety and efficacy.
- These results support the continued development of bemdaneprocel for the treatment of people with Parkinson’s disease.
View references
- Debove I, et al. Mov Disord. 2024;39(2):235-48.
- Khan TS. Cleve Clin J Med. 2012;79 Suppl 2:S8-13.
- Kim TW, et al. Cell Stem Cell. 2021;28(2):343-55.e5.
- Piao J, et al. Cell Stem Cell. 2021;28(2):217-29.e7.
- Kriks S, et al. Nature. 2011;480(7378):547-51.
- Henchcliffe C, et al. Presented at: International Congress of Parkinson’s Disease and Movement Disorders; August 27-31, 2023; Copenhagen, Denmark.
- Hauser RA, et al. Clin Neuropharmacol. 2000;23(2):75-81.
- Goetz CG, et al. MDS-UPDRS. The MDS-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale. Milwaukee, WI: International Parkinson and Movement Disorder Society; 2008.
- Cummings JL, Coffey CE. In: Coffey CE, Cummings JL, eds. The American Psychiatric Press Textbook of Geriatric Neuropsychiatry. Washington, DC: American Psychiatric Press, Inc.; 1994:4-15.
- Peto V, et al. Qual Life Res. 1995;4(3):241-8.
- Chaudhuri KR, et al. Mov Disord. 2007;22(13):1901-11.
