Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Michael J. Fox Foundation for Parkinson's Research

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.