Print

Purpose

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).

Condition

Eligibility

Eligible Ages
Between 50 Years and 79 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MSC+placebo 		2 treatment doses + 1 placebo 3 months apart
  • Drug: MSC+placebo
    2 infusions of 10 X 10^6 MSC/kg and 1 placebo every 3 months.
    Other names:
    • allogeneic mesenchymal stem cell or similar placebo
Experimental
MSC 		3 treatment doses 3 months apart
  • Drug: MSC+placebo
    2 infusions of 10 X 10^6 MSC/kg and 1 placebo every 3 months.
    Other names:
    • allogeneic mesenchymal stem cell or similar placebo
  • Drug: MSC
    3 infusions of 10 X 10^6 MSC/kg every 3 months.
    Other names:
    • allogeneic mesenchymal stem cell
Placebo Comparator
Placebo 		3 placebo doses 3 months apart
  • Drug: Placebo
    3 infusions of placebo every 3 months. Placebo will be identical to the investigational product but will not contain MSCs.
    Other names:
    • Similar placebo

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.