Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mya Schiess
With
Michael J. Fox Foundation for Parkinson's Research
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.
Age
50–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
