NuPlasma yFFP was associated with improvements in complications of therapy, motor examination scores, mentation, behavior, and mood, and in activities of daily living in patients with Parkinson disease.
Dian Ginsberg, MD, staff OB/GYN, Memorial Hermann Hospital and Park Plaza Hospital
Dian Ginsberg, MD
The Neurology Center has announced that the use of 25 ml/kg intravenous NuPlasma young fresh frozen plasma (yFFP) has been associated with statistically significant improvements in a number of neurological assessments for patients with Parkinson disease.1
The 3-month data includes that from 19 patients, 9 of which were administered NuPlasma in 2 doses over 3 days, and 10 were administered placebo. Ultimately, the randomized and double-blind investigation showed yFFP was linked to overall improvements in complications of therapy (50%), motor examinations (19.2%), mentation, behavior, and mood (12.9%), and activities of daily living (7.9%).
The study is being led by a trio of physicians: Dian Ginsberg, MD, staff OB/GYN, Memorial Hermann Hospital and Park Plaza Hospital; Igor Cherches, MD, staff neurologist, the Neurology Center; and Eddie Patton, MD, neurologist and clinical assistant professor, McGovern Medical School at UT Health. Previously, 1-month data had revealed that yFFP recipients achieved improvements in 30 out of 43 assessment categories, with yFFP outperforming the placebo in every assessment subset.2
Ultimately, for patients treated with yFFP, there were a number of motor symptom reductions observed at 3 months, including tremor at rest (-43.8%) and action tremor (-22.2%), as well as a number of instances of bradykinesia (thumb-to-finger, -8.3%; hand open/close, -6.7%; hand and forearm rotation, -23.5%; foot raise, -8.3%). As for body bradykinesia, the plasma group experienced an increase of 3.1%, after a 25% reduction at 1 month. In comparison, the placebo group experienced increases in all tremor and bradykinesia symptoms measured.3
With regard to complications of therapy, patients treated with NuPlasma yFFP experienced larger reductions in both duration of (-60%) and disability from (-100%) dyskinesia compared to those who received placebo (duration, -20%; disability, -20%). Additionally, the yFFP group experienced an 81.3% reduction in off time compared to a 21.9% reduction for the placebo group. Notably, early morning dystonia increased by 68.8% in the yFFP group while the placebo group experienced a 45% reduction.
These results were found “with all patients continuing to be maintained on their pre-investigation treatments, critical disease-conditions such as muscle twitches (dyskinesia), facial expression, speech, handwriting, rigidity and falling, all show improvement directly attributable to the yFFP,” according to The Neurology Center.1
Despite an FDA warning in early 2019 about the misuse of yFFP for a number of conditions—ranging from standard aging and memory loss issues, to conditions such as dementia, Parkinson disease, multiple sclerosis, Alzheimer disease, heart disease, and post-traumatic stress disorder—outside of FDA approved pathways, the treatment method has shown early success in some clinical trials of neurodegenerative diseases.4 In a 2018 study of 9 patients with Alzheimer, yFFP showed it was safe, well tolerated, and feasible enough for Alzheimer disease symptom amelioration in a randomized clinical trial.5
That study’s lead author Sharon J. Sha, MD, MS, told NeurologyLive® that there were “hopeful findings and trends in the exploratory parameters such as functional ability and functional brain connectivity from this very small study” that showed potential to be confirmed in a larger study, something Sha and colleagues noted was warranted.
“It is always our pleasure to discuss our standards, such as the additional testing and hold period we employ, along with the age and gender segmentation,” Tom Casey, CEO, Golden Genesis Inc, the distributor of NuPlasma, told NeurologyLive®. “NuPlasma is not your average blood bank, as we go above and beyond regulatory standards.”
“We employ those higher standards knowing that yFFP is often administered in relatively large volumes Our thirty-day hold allows multiple donations from individual donors to be collected,” he added. Casey explained that the initial donation is released only after a second negative donation is collected, noting that this “rolling release” additionally provides a longer timeframe for the identification of any latent infections.
1. Young Blood Plasma Parkinson's Disease Investigation Three-Month Results Show Dramatic Improvements in Every Neurological Assessment Category [press release]. Houston, TX: The Neurology Center; Published April 24, 2019. prnewswire.com/news-releases/young-blood-plasma-parkinsons-disease-investigation-three-month-results-show-dramatic-improvements-in-every-neurological-assessment-category-300837311.html. Accessed April 25, 2019.
2. Young Blood Plasma Parkinson's Disease Study One-Month Results to Be Introduced at the Texas Neurological Society Winter Conference in Austin on February 1st [press release]. Houston, TX: The Neurology Center; Published January 31, 2019. prnewswire.com/news-releases/young-blood-plasma-parkinsons-disease-study-one-month-results-to-be-introduced-at-the-texas-neurological-society-winter-conference-in-austin-on-february-1st-300787105.html. Accessed April 25, 2019.
3. Ginsberg D, Cherches I, Patton E. Three-Month Parkinson’s Results. Young Plasma Study website. Published April 23, 2019. docs.wixstatic.com/ugd/3e0a14_ea1b78f3658442eda9ac68c830b2ec1f.pdf. Accessed April 25, 2019.
4. Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions [press release]. Silver Spring, MD: FDA; Published February 19, 2019. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631568.htm. Accessed April 25, 2019.
5. Sha SJ, Deutsch GK, Tian L, et al. Safety, tolerability, and feasibility of young plasma infusion in the plasma for Alzheimer symptom amelioration study: a randomized clinical trial. JAMA Neurol. epub October 29, 2018. doi: 10.1001/jamaneurol.2018.3288.