NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04506073

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