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Abstract Details

Preliminary Report on the Safety and Tolerability of Bone marrow-derived Allogeneic Mesenchymal Stem Cells infused intravenously in Parkinson’s disease Patients
Movement Disorders
S16 - Huntington's Disease: From Bench to Clinical Trials (2:17 PM-2:28 PM)
008

Considerable evidence supports a critical role of chronic neuroinflammation in the degenerative process of PD. Through paracrine and exosome actions MSC exerts regenerative and immunomodulatory effects. 

Prove safety and feasibility of allogeneic mesenchymal stem cells (MSC) purified from bone marrow derived from a healthy adult and delivered intravenously in escalated doses to patients with idiopathic Parkinson’s disease (PD).

A total of 20 subjects (M 11: F 9) between 45- 78 years of age who met the UK Brain Bank criteria for idiopathic PD; OFF state H&Y of ≤ 3.  Each dose cohort consists of 5 study subjects that received one of four doses of MSC: 1, 3, 6 or 10 x106 MCS/kg of body weight.  MSC were manufactured by the Pediatrics-Hematology-Oncology Cell & Gene Laboratory. Subjects are evaluated over a year at weeks 3, 12, 24 and 52.  Safety as the primary outcome safety is defined as the absence of transfusion reactions, adverse events or organ damage. Secondary outcomes are defined by therapy impact on PD progression based on UPDRS, TUG, PDQ-39, H&Y, C-SSRS, neuroimaging, and immunologic profile.

All 20 subjects have received a single IV infusion without any adverse reactions in the first 24 hours. In subsequent follow up the most common side effect was hypertension, arthralgia, and nausea (27% for each), which was mild and transient in all cases, not requiring treatment. To date, the first fourteen patients sustained a reduction in UPDRS-III motor score (OFF state) at 12 weeks follow up. 

Preliminary findings from this ongoing small proof-of-concept study, that allogeneic MSC infusions appear to be safe and well tolerated in subjects with mild to moderate Parkinson’s disease. Our preliminary results warrant the completion of the study with the goal of identifying an ideal, well-tolerated dose that is associated with an improvement in cognition, motor function, and disability.

Authors/Disclosures
Mya C. Schiess, MD, FAAN (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.
Timothy M. Ellmore, PhD (The City College of New York) Prof. Ellmore has nothing to disclose.
No disclosure on file
Erin Furr-Stimming, MD, FAAN (University of Texas Health Science Center-Houston) Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Michael J. Fox Foundation. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedPage. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PTC Therapeutics. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedPage. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Wave Life Sciences. Dr. Furr-Stimming has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva Pharmaceuticals. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for PTC Therapeutics. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Wave Life Sciences. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Latus Bio. The institution of Dr. Furr-Stimming has received research support from Roche/Genetech. The institution of Dr. Furr-Stimming has received research support from Uniqure. The institution of Dr. Furr-Stimming has received research support from CHDI. The institution of Dr. Furr-Stimming has received research support from Huntington Study Group/Neurocrine Bioscienes. The institution of Dr. Furr-Stimming has received research support from NIH/University of Iowa. The institution of Dr. Furr-Stimming has received research support from Sage Therapeutics. The institution of Dr. Furr-Stimming has received research support from HDSA. Dr. Furr-Stimming has received publishing royalties from a publication relating to health care. Dr. Furr-Stimming has received publishing royalties from a publication relating to health care. Dr. Furr-Stimming has a non-compensated relationship as a Committee member with AAN UES Committee that is relevant to AAN interests or activities.
No disclosure on file
No disclosure on file
No disclosure on file