Abstract Details

Title Safety and Tolerability of Bone marrow-derived Allogeneic Mesenchymal Stem Cells in Parkinson’s disease Patients

Topic Movement Disorders

Presentation(s) P9 - Poster Session 9 (12:00 PM-1:00 PM)

Poster/Presentation
Number 3-009

Objective Prove safety and feasibility of delivering allogeneic bone marrow-derived mesenchymal stem cells (MSC) intravenously in escalated doses to patients with idiopathic Parkinson’s disease (PD).

Background Neuroinflammation plays a crucial role in the pathogenesis of PD, supporting the rationale for using MSC as immunomodulatory therapy for restoring homeostasis to the neuronal-glial microenvironment.

Design/Methods We recruited 20 subjects with early-moderate disease and tested four doses of MSC: 1, 3, 6, or 10 X 10⁶ MCS/kg. MSC were manufactured under GMP designated by the FDA. Patients were followed for 12 months. Primary outcome was safety, defined as the absence of an immediate transfusion reaction, adverse events or organ damage. Secondary outcomes were defined by therapy impact on PD progression.

Results

All 20 patients received a single IV infusion without any adverse reactions in the first 24hrs. Subsequently, 5 patients (25%) developed hypertension, arthralgia, and nausea. HTN was transient in all cases except 1 with Stage 2 HTN. Arthralgia and nausea were transient. One patient with a 4-year history of lymphocytosis was diagnosed with CLL.
Recipient PRA did not show any response to donor HLA.
There was a significant down-regulation of TNF-alpha, MCP-1, MDC, IP-10, Eotaxin, and an increase in BDNF.
All 20 patients sustained motor improvement in the OFF state. The highest dose had the most substantial effect on reducing UPDRS total, UPDRS motor, and H&Y scores. This was also the case for quality of life measure using PDQ-39 and cognition assessed by MOCA.

Conclusions This study demonstrates that allogeneic MSC infusions are safe and well-tolerated in subjects with mild-moderate PD. Our data points towards a treatment effect that relies on peripheral immune modulation. There is a potential signal for clinical improvement (OFF state motor scores), but this should be interpreted with caution based on both the limited sample size and the purpose of the study.

Authors/Disclosures
Mya C. Schiess, MD, F�鶹��ýӳ�� (Univ of Texas-Houston Med School) PRESENTER	Dr. Schiess has nothing to disclose.
Jessika Suescun, MD (University of Texas)	Dr. Suescun has nothing to disclose.
	No disclosure on file
Christopher Adams, MD (The University of Washington)	Dr. Adams has stock in Medtronic.
Charles Green	Charles Green has received personal compensation in the range of $500-$4,999 for serving as a Consultant for University of Texas at Austin. Charles Green has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Baylor College of Medicine. Charles Green has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Society of Research on Nicotine and Tobacco. Charles Green has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Society for Psychophysiology. The institution of Charles Green has received research support from NIH. The institution of Charles Green has received research support from DoD. The institution of Charles Green has received research support from VA. The institution of Charles Green has received research support from Michael J. Fox Foundation. The institution of Charles Green has received research support from American Association for Cancer Research.
	No disclosure on file
Timothy M. Ellmore, PhD (The City College of New York)	Prof. Ellmore has nothing to disclose.

�鶹��ýӳ��

�鶹��ýӳ��