Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
NCT ID: NCT04506073
Last Updated: 2024-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2020-11-09
2023-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mesenchymal Stem Cells and Placebo
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells
1 dose is 10 X 10\^6 MSC/kg
Placebo
Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
Mesenchymal Stem Cells
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells
1 dose is 10 X 10\^6 MSC/kg
Placebo
3 placebo doses administered every 4 months.
Placebo
Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
Interventions
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Mesenchymal Stem Cells
1 dose is 10 X 10\^6 MSC/kg
Placebo
Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
79 Years
ALL
No
Sponsors
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Michael J. Fox Foundation for Parkinson's Research
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Mya Schiess
Professor and Adriana Blood Chair in Neurology
Principal Investigators
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Mya C Schiess, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.
Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.
Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83. doi: 10.1001/jama.2014.3654.
Jellinger KA. Basic mechanisms of neurodegeneration: a critical update. J Cell Mol Med. 2010 Mar;14(3):457-87. doi: 10.1111/j.1582-4934.2010.01010.x. Epub 2010 Jan 11.
Kortekaas R, Leenders KL, van Oostrom JC, Vaalburg W, Bart J, Willemsen AT, Hendrikse NH. Blood-brain barrier dysfunction in parkinsonian midbrain in vivo. Ann Neurol. 2005 Feb;57(2):176-9. doi: 10.1002/ana.20369.
Gray MT, Woulfe JM. Striatal blood-brain barrier permeability in Parkinson's disease. J Cereb Blood Flow Metab. 2015 May;35(5):747-50. doi: 10.1038/jcbfm.2015.32. Epub 2015 Mar 11.
Orr CF, Rowe DB, Halliday GM. An inflammatory review of Parkinson's disease. Prog Neurobiol. 2002 Dec;68(5):325-40. doi: 10.1016/s0301-0082(02)00127-2.
Nagatsu T, Mogi M, Ichinose H, Togari A. Cytokines in Parkinson's disease. J Neural Transm Suppl. 2000;(58):143-51.
Stypula G, Kunert-Radek J, Stepien H, Zylinska K, Pawlikowski M. Evaluation of interleukins, ACTH, cortisol and prolactin concentrations in the blood of patients with parkinson's disease. Neuroimmunomodulation. 1996 Mar-Jun;3(2-3):131-4. doi: 10.1159/000097237.
Joyce N, Annett G, Wirthlin L, Olson S, Bauer G, Nolta JA. Mesenchymal stem cells for the treatment of neurodegenerative disease. Regen Med. 2010 Nov;5(6):933-46. doi: 10.2217/rme.10.72.
Martinez-Lemus JD, Molony DA, Suescun J, Tharp E, Thomas TS, Green C, Onuigbo C, Ritter R 3rd, Schiess MC. Allogeneic bone marrow-derived mesenchymal stem cells in the aging kidney: secondary results of a Parkinson's disease clinical trial. Stem Cell Res Ther. 2025 Sep 24;16(1):493. doi: 10.1186/s13287-025-04577-y.
Other Identifiers
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HSC-MS-20-0150
Identifier Type: -
Identifier Source: org_study_id
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