Status:
COMPLETED
Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson's Disease
Eligibility:
All Genders
50-79 years
Phase:
PHASE2
Brief 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...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04506073
Start Date
November 9 2020
End Date
July 30 2023
Last Update
July 26 2024
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030