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Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
CompletedPhase 2
Sponsor: Mya Schiess
Conditions: Parkinson's Disease
Interventions: Mesenchymal Stem Cells, Placebo
Countries: United States
The purpose of this study is to select the safest and most effective number of repeat doses of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the progression of Parkinson's disease (PD).
Eligibility overview
Sex: ALL
Age: 50 Years to 79 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease by the UK brain bank criteria including the presence of 2 cardinal signs of PD plus bradykinesia. * Mild microsomia to anosmia. * A modified Hoehn and Yahr stage of 3 or less. * Date of diagnosis of PD between 3 to 10 years * Robust response to dopaminergic therapy. Exclusion Criteria: * Atypical, vascular, or drug-induced Parkinsonism. * An atypical DAT scan or MRI supporting an alternative explanation for PD symptoms. * Patient not on levodopa containing medications. * Clinical features of psychosis or refractory hallucinations. * A Montreal Cognitive Assessment (MoCA) score of less than 25. * Uncontrolled seizure disorder. * Abnormal Kidney and liver function. * Presence of clinically refractory orthostatic hypotension at the screening or baseline visit. * Body mass index of greater than or equal to 35. * Cardiac disease: History of congestive heart failure, clinically significant bradycardia, presence of 2nd, or 3rd-degree atrioventricular block. * Pulmonary disease: COPD with oxygen-requirement at rest or with ambulation; or moderate to severe asthma. * Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening * Any current suicidal ideation or behaviors. * Any diagnosis of autoimmune disease or immunocompromised state * History of medium or large size vessel cerebrovascular accidents. * History of traumatic brain injury with loss of consciousness and residual neurologic symptoms. * Major surgery within the previous 3 months or planned in the ensuing 6 months. * History of use of an investigational drug within 90 days prior to the screening visit. * History of brain surgery for PD. * Substance abuse disorder. * Active anticoagulation treatment and/or abnormal INR.
Locations (1)
- Houston, Texas, United States