Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease

A Randomized, Double-blind, Placebo-controlled Trial of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease

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).

Single site phase IIa study of allogeneic MSC in a double blind randomized control trial as disease modifying therapy for PD. The design includes three treatment arms with 45 patients.

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.